Petition for Writ of Certiorari — Martello v. CIBA Vision Corp.

Supreme Court brief1995

Ask Donna

What actually matters in this document.

Text

Supreme Court, U.s. ;

PILED

941832 MAY 981995

No. OFFICE OF THE CLERK

In The

Supreme Court of the United States

October Term, 1994

-¢

SUBBY MARTELLO,

Petitioner,

VS.

CIBA VISION CORPORATION,

A Georgia Corporation,

Respondent.

=—®

On Petition For Writ Of Certiorari

To The United States Court Of Appeals

For The Eighth Circuit

PETITION FOR WRIT OF CERTIORARI

James R. WetsH

BRADFORD, COENEN & WELSH

1850 First National Center

1620 Dodge Street

Omaha, NE 68102-1505

(402) 342-4200

COCKLE LAW BRIEF PRINTING CO. (800) 225-6964

OR CALL COLLECT (402) 342-2831

QUESTION PRESENTED

Did the Circuit Court err when it held that federal

regulation of class III Medical devices, despite an absence

of a specific regulation or guideline, preempted state

common law?

PARTIES INVOLVED IN THE PROCEEDINGS BELOW

SUBBY MARTELLO, Plaintiff, and

CIBA VISION CORPORATION, A Georgia Corpora-

tion, Defendant.

i ¥

Daca

1 aye

Questions Presented os

Parties Involved in the Proceedings Below. li

Table of Contents . ) Po ae

Table of Authorities eee ice 2 A. ae

Reference to Official and Unofficial Reports of

Dee eee ep ub eeseeuds l

ee Re l

Statutes and Provisions Involved ........ Se

NS ES I a 2

Argument...... Sonata 60 43% Rees cn eax 3

ESE a ee App. 1

TABLE OF AUTHORITIES

Page

Cases

Anguiano v. EJ. Dupont De Nemours & Company,

Fic., 44 F.3a S06 Gh Cie. 1995)... 2. ccc cess ee

Cippollone v. Liggett Group, Inc., 505 U.S. __, 112

S.Ct. 2608, 120 L.Ed.2d 407 (1992) ............5, 6, 9

CSX Transportation, Inc. v. Easterwood, ___ U.S. __,

113 S.Ct. 1732, 123 L.Ed.2d 387 (1993) ...5, 6, 7, 8, 9

King v. Collagen Corp., 983 F.2d 1130 (ist Cir. 1993),

cert. denied, ___ U.S. __, 114 S.Ct. 84, 126

Ee ae EDs ok 4 eh ardsalbia eo oe cae ek Ee Ree 3

Stamps v. Collagen Corp., 984 F.2d 1416 (5th Cir.

1993), cert. denied, __~:U.S. __, 114 S.Ct. 86, 126

ke Ee er ee ere re reer ore ry eee 3

STATUTES AND OTHER AUTHORITIES

en ae, Cr daa Ube he ee iG nies hase eas 3

ae Eee: ee cs No has Bh ee ee ee

ae Sr, TD. GI 3S 434k oa uS ek bes asaeeendyasnew l

Oe Acs Se (IEEE fk o's Sods Seow eeeuni keane: ie

ae Se EC cs poke eke ecr eh anreed een awed ]

ek ee Oe we ewe ROR ET 1, 4

ee eS EE goa vk ea haw eee eee pees ]

ee Cree Pe, TE 96 6 oh 6 Oo oak sche dah edteehs eae 1

Be Cree STIR TIN kn ok eae ecw edccnnasees ]

Federal Cigarette Labeling and Advertising Act......5

Federal Food, Drug & Cosmetics Act ................ 2

TIES Continued

Page

Medical Device Amendments of 1976 2, 3, 4

Public Health Cigarette Smoking Act 5

Railroad Safety Act 7

D. REFERENCE TO OFFICIAL AND UNOFFI-

CIAL REPORTS OF DECISIONS

The opinion in this case was officially reported as

Martello v. Ciba Vision Corporation, 42 F.3d 1167 (8th Cir.

1994).

E. GROUNDS OF JURISDICTION

1. The original opinion was entered on December

12, 1994.

2. Appellants motion for rehearing was denied on

February 7, 1995.

3. Jurisdiction of this Court is invoked pursuant to

28 USC Sec. 1254(1).

F. STATUTES AND PROVISIONS INVOLVED

Due to the length of the provisions involved in this

case, only the citations thereto are included herein with

the full text included in the appendix.

360¢

360e

360k

814.20

808

808.1

860.7

886.5928

21 USC

21 CFR

MMMM ummnmn

G. STATEMENT OF THE CASE

The Plaintiff suffered an infection and was blinded in

one eye after using the Defendant's soft contact lens

cleaning system. The blindness of the Plaintiff was

alleged to have resulted from his use of the system and

this action alleging strict liability, breach of warranty and

negligence claims against the Defendant was instituted.

The Defendant moved for, and was granted, sum-

mary judgment on the basis of preemption of Plaintiff's

state law claims by the Medical Device Amendments of

1976. Because the Defendant's product was a Class III

device under that act, it was subjected to strenuous pre-

marketing testing and review by a panel of FDA experts.

The District Court held, and the 8th Circuit agreed, that

approval by the FDA of a Class II Medical device pre-

empts state law claims arising from that device’s manu-

facture. The Courts held that Section 360K preempis the

claims of the Plaintiff.

The Appellant argued below and reasserts here that

the Courts which have held that the MDA preempts

common law claims are wrong, their holdings are in

direct conflict with prior holdings of this Court, and

allow federal preemption to occur when no specific stat-

ute or regulation requires it. There is no regulation set-

ting forth the safety standards to be applied to a contact

lens system. Rather the only effective regulations are

those requiring FDA approval of the device. Under these

circumstances, the Appellant submits no preemption

exists.

ARGUMENT

The rationale of the courts below was that the

requirements of 21 U.S.C. Section 360k preempted the

plaintiff's common law causes of action. 21 U.S.C. Sec-

tions 360c et seq., contain the Medical Device Amend-

ments of 1976 to the Federal Food, Drug & Cosmetics Act.

Those amendments made medical devices subject to regu-

lation by the FDA. When the amendments were passed,

Congress passed a specific federal preemption section

relating to medical devices. That section, contained at 21

U.S.C. Section 360k is set forth above.

The reasoning of the Eighth Circuit in the court

below was consistent with the reasoning of other circuits

that have considered this question. See King v. Collagen

Corp., 983 F.2d 1130 (1st Cir. 1993) cert. denied __ U‘S.

_, 114 S.Ct. 84, 126 L.Ed.2d 52 (1993) and Stamps v.

Collagen Corp., 984 F.2d 1416 (5th Cir. 1993) cert. denied

aw WD ue 114 S.Ct. 86, 126 L.Ed. 2d 54 (1993).

Each of the above cases have held that preemption

occurs because, when dealing with a Class III medical

device, the intent of the Federal Government was that the

demands placed upon the manufacturer of such a device

preempt any state law claims regarding the safety or

manufacture of the device. This is true, even though there

is no specific regulation in the MDA setting forth the

requirements for a Class III medical device.

“Dupont argued that, regardless of the absence

of specific provisions regarding PPFE, the basic

statutory framework of the MDA requiring all

medical devices to be registered, classified and

approved by the FDA, 21 U.S.C. Section 340,

establishes the necessary requirements to pre-

empt state law. The MDA divides medical

devices into three classes. . . . Class III devices

present a potential unreasonable risk of illness

or injury and thus require premarket approval, a

stringent process requiring the manufacturer to

submit detailed information to an FDA panel of

experts. Id, at 1419....

Because of the more extensive requirements imposed

on Class III devices, the MDA preempts state law

regarding a Class III device, even if the only MDA

regulation specifically addressing the device is an

identification regulation. ...” Anguiano v. E. 1. Du

Pont De Nemours & Company, Inc., 44 F.3d 806,

810 (9th Cir. 1995).

Thus, what the Court is dealing with in the MDA

cases is a federal regulatory scheme which, instead of

enacting safety standards by regulation or rule instead

attempts to delegate the responsibility for making such

regulations to a panel of experts who then approves or

disapproves of a device based upon unpublished stan-

dards and without public input. The Courts have, in

contravention of this Court’s analysis of federal preemp-

tion, given this panel of expert’s opinions the iorce of

federal law and preempted state common law in the field.

Pursuant to the provisions of that Act, the Depart-

ment of Health and Human Services enacted regulations

dealing with the federal preemption section. Those regu-

lations directly applicable to the issue at bar are found at

21 CFR Section 808.1, and are set forth fully herein.

The cases of Cippollone v. Liggett Group, Inc., 505 U.S.

___, 112 S.Ct. 2608, 120 L.Ed.2d 407 (1992) and CSX Trans-

portation, Inc. v. Easterwood, __ U.S. __, 113 S.Ct. 1732,

123 L.Ed.2d 387 (1993), are of primary importance to the

issue.

In Cippollone, this Court held that a provision of the

Public Health Cigarette Smoking Act of 1965 requiring

cigarette manufacturers to place a warning on their pack-

aging, but further holding that no other statements may

be required on any cigarette package, did not preempt

common law claims against cigarette manufacturers

based on products liability and failure to warn.

This Court held that, because preemption matters

mrust be decided narrowly and with the understanding

that preemption is not a favored doctrine, that the 1965

Act only preempted state and federal rule making bodies

from mandating particular cautionary statements and did

not pre-empt state law damage actions.

The Court went on to hold that a 1969 amendment to

the Act which barred the imposition of any requirements

or prohibitions under state law. The Court held that the

proper analysis was to narrowly, but fairly, construe the

federal law and compare it with the legal duty that is the

predicate of the common law damages action and see

whether that action was specifically preempted by the

statute. 112 S.Ct. 2621.

Cippollone contains several points favorable to the

appellant:

1) The preemption clause considered in Cippollone

was broad, all encompassing, and contained no reserva-

tion of rights to the states or regulation of cigarette pro-

motion, packaging and advertising;

2) Despite the broad preemptive statutory language

considered in Cippollone, the Supreme Court still held that

claims of plaintiffs based upon fraudulent misrepresenta-

tions; breach of implied warranty; and other common law

claims not specifically addressed by the Act were not

preempted by federal law; and

3) The Supreme Court rejected the theory of the

Court of Appeals that the preemption clause contained in

the statute was to be read broadly. Rather, the Supreme

Court employed a narrow construction of the statute

consistent with its previous law that claims of preemp-

tion were to be narrowly construed.

The Supreme Court in Cippollone held that specific

areas regulated under the Act were preempted, while

other theories against cigarette manufacturers not speci-

fically mentioned in the Act or regulations, were not

preempted.

Thus, Cippollone can be read to demonstrate a legiti-

mate hostility to any theory of preemption that goes

beyond the necessary literal interpretation of federal stat-

utes, regulations and rules.

In the case of CSX Transportation, Inc. v. Easterwood,

__-;U.S. __, 113 S.Ct. 1732, 123 L.Ed.2d 387 (1993), this

Court considered the issues of preemption in regard to

application of the Federal Railroad Safety Act. That Act

(like the Food & Drug Act involved in this case) has both

an explicit preemption clause and an explicit savings

clause.

The Court noted that the different circuits had

adopted conflicting standards of review of claims of pre-

emption relating to the Railroad Safety Act. (113 S.Ct.

1732, 1734, n.1) The Court, in determining the standard to

be applied, stated:

Where a state statute conflicts with or frustrates

federal law, the former must give way... In the

interest of avoiding unintended encroachment

on the authority of the states, however, a court

interpreting a federal statute pertaining to a

subject traditionally governed by state law will

be reluctant to find preemption. Thus, preemp-

tion will not lie unless it is the ‘clear and mani-

fest purpose of Congress.’ . . . Evidence of

preemptive purpose is sought in the text and

structure of the statute at issue... . If the statute

contains an express preemption clause, the test

of statutory construction must in the first

instance focus on the plain wording of the

clause, which necessarily contains the best evi-

dence of Congress’ preemptive intent.” 113 S.Ct.

132, 137.

The Court in CSX then went on to note that the

preemption clause of the statute was bracketed by an

express saving clause. The Court noted that the preemp-

tion language displayed “considerable solicitude for state

law.” 113 S.Ct. 1732, 1738.

The Court in CSX then went on to a detailed analysis

of the regulations issued by the Secretary of Transporta-

tion in compliance with the Act. It was the analysis of the

Court that the regulations, in and of themselves, deter-

mined the extent of regulation by the federal government

and thus determined the extent of preemption assumed

by the federal government

CSX is important tor the following reason:

1. It emphasizes that the amount of preemption, if

any, incurred as a result of a federal statute, depends

upon the express wording of that statute;

2. It demonstrates that when Congress has indi-

cated a solicitude for a state law, that solicitude should be

utilized in the analysis of the statute; and

3. It indicates the overriding importance of the lan-

guage of the federal regulations involved in the case.

A review of the requirements of the Act show clearly

that the contact lens cleaner manufactured by the defen-

dant in this case is, essentially, unregulated by the FDA.

While approval of the FDA is necessary prior to market-

ing of the device, no substantive regulations exist dictat-

ing desigr standards, standards of manufacture,

warnings, labels, warranties, remedies, or any other

related matters. The only requirement is that the com-

pany get advance approval to market the device. There

are no regulations in effect which have been published

determining what these standards are.

If the FDA published regulations specifically stating

what the design of the machines were, what materials

could be used in them, how they were to be manufac-

tured, how they were to be labeled, what warnings were

to be put on them, and similar matters, the plaintiff

concedes that preemption would apply. However, the

FDA has not done this. The appellant has been unable to

find any regulation explicitly dealing with any of the

issues involved in this case. By the language of the Act,

and the interpretation of the government under the Act,

as set forth in the regulations governing preemption, the

common law theories of negligence, strict liability, and

breach of warranty, are not “different from” or “in addi-

tion to” “requirements applicable under this chapter.”

Because no federal regulation or statute has set safety

standards for the contact lens cleaners in this case, fed-

eral preemption should not have been found. Neverthe-

less, the various courts of appeals of this Country have

adopted a rule of law that state common law rules of

negligence, implied warranty and strict liability do not

apply in the cases of Class III medical devices. They have

done so in contravention of this Court’s rulings in Cip-

pollone and CSX. Certiorari should be granted to consider

whether the circuit courts of appeals have misinterpreted

this Court’s intention in those cases and have misapplied

the law to the detriment of both the plaintiffs who have

been injured and to the various States whose common

law and regulations have been deemed preempted.

Respectfully submitted,

James R. Wetso — #14459

BRADFORD, COENEN & WELSH

1850 First National Center

1620 Dodge Street

Omaha, Nebraska 68102-1505

(402) 342-4200

App. 1

UNITED STATES COURT OF APPEALS

FOR THE EIGHTH CIRCUIT

No. 94-1206NE

Subby Marteilo, ,

Appellant, * Appeal from the

V. . United States

* District Court for

: the District of

' Nebraska.

Appellee. *

Ciba Vision Corporation,

A Georgia Corporation,

Submitted: October 14, 1994

Filed: December 12, 1994

Before FAGG, Circuit Judge, ROSS, Senior Circuit Judge,

and MAGILL, Circuit Judge.

FAGG, Circuit Judge.

Subby Martello developed a corneal infection and

lost vision in one eye after using CIBA AOSEPT Catalytic

Disinfection System (AOSEPT), a soft contact lens disin-

fection system manufactured by Ciba Vision Corporation.

Alleging AOSEPT caused his loss, Martello brought this

products liability action against Ciba Vision raising state

tort claims of strict liability, breach of express and

implied warranties, and negligence related to AOSEPT’s

design, inspection, instructions, labelling, warning, and

App. 2

testing. The district court granted summary judgment to

Ciba Vision, holding Martello’s claims are expressly pre-

empted by the Medical Device Amendments Act of 1976

(MDA), 21 U.S.C. §§ 360c-360k (1988 & Supp. V 1993).

Martello appeals and we affirm.

The MDA gives the Food and Drug Administration

(FDA) authority over medical devices and authorizes the

FDA to issue implementing regulations. Under the MDA,

medical device manufacturers must register each device

with the FDA before beginning manufacture. See 21

U.S.C. § 360c. After registration, the FDA classifies each

device according to the level of regulatory control neces-

sary to provide for the device’s safety and effectiveness.

See id. Because Class I devices present the least risk of

harm, they are the most loosely regulated and are sub-

jected only to general controls. Id. § 360c(a)(1)(A). Class II

devices, including artificial knee joints and tampons, are

more heavily regulated and are subject to special con-

trols. Id. § 360c(a)(1)(B). Class III devices, like artificial

heart valves and contact lens solutions, are the most

heavily regulated and must pass premarket approval. Id.

§ 360c(a)(1) (C). To obtain premarket approval, the manu-

facturer must submit detailed information about the

device's testing, design, components, performance stan-

dards, manufacturing, packaging, and labelling. See id.

§ 360e(c)(1); 21 C.F.R. § 814.20 (1994). After a panel of

experts reviews the application, 21 U.S.C. § 360e(c)(2), the

FDA may approve the device for sale if valid scientific

evidence reasonably assures the device's safety and effec-

tiveness, see id. § 360c(a)(2); 21 C.F.R. § 860.7. When a

device has been approved for sale, the manufacturer must

App. 3

maintain certain records and continue to report to the

FDA about the device. 21 U.S.C. § 360i.

The district court held Martello’s claims were

expressly preempted under the MDA’s preemption provi-

sion, 21 U.S.C. § 360k(a). Under § 360k(a), a state cannot

establish a requirement that relates to a device's safety or

effectiveness and that differs from, or adds to, any MDA

requirement applicable to the device. The FDA has inter-

preted § 360k(a) as preempting any state requirement,

“whether established by statute, ordinance, regulation, or

court decision.” 21 C.F.R. § 808.1(b). Thus, the MDA’s

preemptive effect extends to state tort actions. National

Bank of Commerce v. Kimberly-Clark Corp., No. 93-3012,

1994 WL 580798, at *2 (8th Cir. Oct. 25, 1994); Stamps v.

Collagen Corp., 984 F.2d 1416, 1421 (5th Cir.), cert. denied,

114. S. Ct. 86 (1993); Lamontagne v. E.I. Du Pont de Nemours

& Co., 834 F. Supp. 576, 582 (D. Conn. 1993) (citing cases).

In a regulation interpreting § 360k(a), the FDA has indi-

cated, “State . . . requirements are preempted only when

the [FDA] has established specific counterpart regula-

tions or there are other specific requirements applicable

to a particular device under the [MDA]. . . making any

existing divergent [s]tate . . . requirements applicable to

the device different from, or in addition to, the specific

[FDA] requirements.” 21 C.F.R. § 808.1(d). Put another

way, “[P]reemption does not apply when the FDA has

issued no regulations or other requirements specific to

the particular device.” King v. Collagen Corp., 983 F.2d

1130, 1134 (1st Cir.), cert. denied, 114 S. Ct. 84 (1993). The

FDA’s regulations interpreting § 360k(a) are controlling.

See id. Thus, a state tort claim is preempted only if (1) the

FDA has established regulations specific to the medical

App. 4

device in issue, (2) the state claim imposes a requirement

different from, or in addition to, any FDA requirement

for the device, and (3) the claim relates to the safety or

effectiveness of the device, or to any other matter

included in an MDA requirement for the device. Lamon-

tagne, 834 F. Supp. at 583.

Martello concedes AOSEPT is a Class III medical

device under the MDA. See 21 C.F.R. § 886.5928 (defining

soft contact lens solution as a device intended to clean,

disinfect, wet, or store a soft contact lens, and assigning

Class III). Martello also concedes the FDA had approved

Ciba Vision’s premarket application for AOSEPT before

Martello used the product. Nevertheless, Martello con-

tends his claims are not preempted because the regula-

tions contain no specific requirements for soft contact

lens disinfection systems. We disagree.

The premarket approval process is a specific require-

ment for a device within the meaning of 21 U.S.C.

§ 360k(a) and 21 C.F.R. § 808.1(d). Stamps, 984 F.2d at

1421-22; Bravman v. Baxter Healthcare Corp., 842 F. Supp.

747, 760-61 (S.D.N.Y. 1994); see also Slater v. Optical Radia-

tion Corp., 961 F.2d 1330, 1333 (7th Cir.) (MDA’s pro-

cedural requirements have same preemptive effect as

substantive requirements), cert. denied, 113 S. Ct. 327

(1992). The MDA thus expressly preempts state tort

claims involving the safety and effectiveness of Class III

devices when the claims would impose additional

requirements in areas regulated through the premarket

approval process. Stamps, 984 F.2d at 1421-22; King, 983

F.2d at 1134; Brown v. Medtronic, Inc., 852 F. Supp. 717,

719-20 (S.D. Ind. 1994) (citing cases). Under this rule,

courts have held the MDA preempts state law claims of

App. 5

strict liability, breach of express and implied warranties,

misrepresentation, failure to warn, and negligence in

design, manufacturing, and labelling of Class II devices

because the claims involve areas regulated through the

premarket application process. Stamps, 984 F.2d at

1421-22; King, 983 F.2d at 1134.

FDA approval of a premarket application shows the

FDA has reviewed a device’s testing, design specifica-

tions, intended use, manufacturing method, performance

standard, and labelling, see 21 U.S.C. § 360e(c)(1), and

decided the device is safe and effective, see id. § 360c(a)

(2). Here, all of Martello’s state tort claims deal directly

with AOSEPT’s safety and effectiveness and would add

requirements in areas reviewed in the premarket

approval process. Martello did not claim the AOSEPT he

used did not comply with federal regulations, see Reiter v.

Zimmer, Inc., 830 F. Supp. 199, 204 (S.D.N.Y. 1993), or that

the AOSEPT he used was contaminated, see King, 983 F.2d

at 1135 (21 U.S.C. § 360k(a) does not preempt contami-

nated device claim); Slater, 961 F.2d at 1334 (same);

Mendes v. Medtronic, Inc., 18 F.3d 13, 19 (1st Cir. 1994)

(explaining contaminated device claim); 21 C.F.K.

§ 808.1(d)(6)(ii).

Because Martello’s claims are expressly preempted

under the MDA, we affirm the district court’s grant of

summary judgment to Ciba Vision.

A true copy.

Attest:

CLERK, U.S. COURT OF APPEALS, EIGHTH

CIRCUIT.

App. 6

UNITED STATES COURT OF APPEALS

FOR THE EIGHTH CIRCUIT

No. 94-1206NEO

Subby Martello, .

A sllant,

sibs * Appeal from the

Vv. . United States

* District Court for

. the District of

. Nebraska

Appellee. .

Ciba Vision Corporation,

A Georgia Corporation,

JUDGMENT

(Filed Feb. 17, 1995)

This appeal from the United States District Court was

submitted on the record of the district court, briefs of the

parties and was argued by counsel.

After consideration, it is hereby ordered and

adjudged that the judgment of the district court in this

cause is affirmed in accordance with the opinion of this

Court.

December 12, 1994

A true copy.

ATTEST: Michael E. Gans

CLERK, U.S. COURT OF APPEALS,

EIGHTH CIRCUIT.

App. 7

IN THE UNITED STATES DISTRICT COURT FOR THE

DISTRICT OF NEBRASKA

SUBBY MARTELLO, )

Plaintiff, ) 8:CV91-00121

: 7 ORDER AND

, JUDGMENT

CIBA VISION CORPORATION, )

a Georgia corporation (Tied

. ) Dec. 21, 1993)

Defendant. )

)

Pursuant to the memorandum opinion entered herein

this date,

IT IS ORDERED that defendant’s motion for sum-

mary judgment (Filing No. 72) is granted. Plaintiff's com-

plaint is dismissed.

DATED this 21st day of December, 1993.

BY THE COURT:

/s/ Lyle E. Strom

LYLE E. STROM, Chief Judge

United States District Court

App. 8

IN THE UNITED STATES DISTRICT COURT FOR THE

DISTRICT OF NEBRASKA

SUBBY MARTELLO,

Plaintiff, 8:CV91-00121

” MEMORANDUM

OPINION

CIBA VISION CORPORATION,

e iac ation,

a Georgia corporati (Filed Dec. 21, 1993)

Defendant.

This matter is before the Court on defendant's

motion for summary judgment filed pursuant to Fed. R.

Civ. P. 56(c). (Filing No. 72). The Court has jurisdiction

over this matter pursuant to 28 U.S.C. §§ 1332(a) and

1441(a).

To succeed in this motion, defendant must show that

no genuine issue of material fact exists, and that it is

entitled to judgment as a matter of law. Fed. R. Civ. P.

56(c); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 250

(1986). For purposes of summary judgment, “genuine”

refers to whether the material issue has any real basis on

the record. Hartnagel v. Norman, 953 F.2d 394, 395 (8th Cir.

1992) (citing Matsushita Elec. Indus. Co. v. Zenith Radio

Corp., 475 U.S. 574, 586-87 (1986)). “Material” refers to

whether the genuine issue of fact could “affect the out-

come of the suit.” Id. (quoting Anderson v. Liberty Lobby,

Inc., 477 U.S. 242, 248 (1986)). Upon review of a motion

for summary judgment, the Court must give the party

App. 9

opposing the motion the benefit of all favorable infer-

ences. Holloway v. Lockhart, 813 F.2d 874, 878 (8th Cir.

1987).

II.

On January 31, 1991, plaintiff filed a petition in the

District Court of Douglas County, Nebraska. On March 4,

1991, defendant removed the case to this Court. In his

complaint, plaintiff alleges that defendant’s contact lens

disinfectant system, Ciba AOSEPT Catalytic Disinfection

System (“AOSEPT”), caused him to develop an eye infec-

tion, acanthamoeba corneal infection, which eventually

resulted in a near complete vision loss in his right eye

and severe shock to the nervous system. Plaintiff asserts

theories of recovery based on strict liability, negligence,

and breach of express and implied warranties.

Defendant bases its summary judgment motion pri-

marily on the doctrine of preemption. Specifically, defen-

dant argues that the Medical Device Amendments of 1976

(“MDA”), 21 U.S.C. §§ 360c through 360k, expressly pre-

empt plaintiff’s state law tort claims.

In 1976, Congress amended the Food, Drug and Cos-

metic Act to bring “medical devices” within the jurisdic-

tion of the Food and Drug Administration (FDA).

Medical Device Amendments of 1976, 21 U.S.C. §§ 360c -

360k. The amendments are designed to protect the public

from hazardous medical devices by empowering the FDA

to set national safety standards. See 1976 U.S. Code Cong.

& Admin. News at pp. 1070, 1071. In the regulations

promulgated pursuant to these amendments, soft contact

lens disinfectant solutions, such as AOSEPT, are classified

App. 10

as Class III medical devices. 21 C.F.R. § 886.5928. Class III

devices are required to undergo premarket approval

(“PMA”), the purpose of which is to “provide reasonable

assurance of [the device’s] safety and effectiveness.” 21

U.S.C. §360c(a)(1)(C). To obtain PMA, the manufacturer

must submit all information bearing on the safety and

effectiveness of the device, as well as any proposed label-

ing to the Secretary. 21 U.S.C. § 360e(c)(1). Based on the

information submitted, the FDA must approve or deny

application for PMA. 21 U.S.C. § 360e(d)(2).

The contact lens solution which is the subject of this

case has completed the PMA procedure for class III medi-

cal devices. On June 10, 1982, the FDA informed the

defendant that the initial review of the defendant’s PMA

application was complete and that the application was

suitable for filing. The letter stated that the application

would next undergo a scientific and compliance review.

(Dennis Aff. Filing No. 73, J 2, Ex. 1). On March 17, 1983,

the FDA approved the defendant’s PMA application for

the disinfection system, for use in disinfecting SOFTCON

contact lenses. (Dennis Aff. { 3, Filing No. 73, Ex. 2). On

April 8, 1983, the FDA announced this approval in the

Federal Register. 48 Fed. Reg. 15,327-15,328 (April 8,

1983). On December 23, 1983, the FDA approved the

defendant's disinfection system for use in disinfecting all

types of contact lenses. (Dennis Aff. 1 5, Filing No. 73, Ex.

4). Thus, in 1987, when the plaintiff used the defendant's

contact lens disinfecting solution, the solution was classi-

fied as a class III medical device.

App. 11

III.

It is a familiar and well-established principle that the

Supremacy Clause of the United States Constitution

invalidates state laws that “interfere with, or are contrary

to,” federal law. Hillsborough County v. Automated Medical

Labs., Inc., 471 U.S. 707, 712 (1985) (quoting Gibbons v.

Ogden, 9 Wheat. 1, 211 (1824) (Marshall, C.J.)). In general,

state laws are preempted if they actually conflict with an

express or implied federal declaration, or if the state law

effects an area that is so pervasively controlled by federal

law that no room is left for state rulemaking. See Fidelity

Fed. Sav. & Loan Ass‘n v. de la Cuesta, 458 U.S. 141, 143

(1982); See also Karl v. Burlington Northern R. Co., 880 F.2d

68, 77 (8th Cir. 1989).

In the interest of avoiding unintended encroachment

on the authority of the States, courts have been generally

reluctant to find a federal statute preempts state or local

requirements which pertain to an area of the law “tradi-

tionally governed by state law.” CSX Transp., Inc. v. East-

erwood, 113 S.Ct. 1732, 1737, 123 L. Ed. 2d 387, 396 (1993).

In such cases, courts will not find preemption unless it is

“the clear and manifest purpose of Congress.” Id. (quot-

ing Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947).

Thus, because state law traditionally governs matters

related to health and safety, Hillsborough, 471 U.S. at 715,

the Court must “focus on the plain wording of the clause,

which necessarily contains the best evidence of Congress’

preemptive intent.” CSX Transp., Inc. 113 S. Ct. at 1737,

123 L. Ed. 2d at 396.

App. 12

In the present case, the amendments contain a provi-

sion expressly addressing their intended preemptive

scope:

Except as provided in subsection (b) of this

section [which is inapplicable to this case], no

State or political subdivision of a State may

establish or continue in effect with respect to a

device intended for human use any requirement -

(1) which is different from, or in addition

to, any requirement applicable under this chap-

ter to the device, and

(2) which relates to the safety or effective-

ness of the device or to any other matter

included in a requirement applicable to the

device under this chapter.

21 U.S.C. § 360k(a). Pursuant to this statute, which

applies to state and local requirements “established by

statute, ordinance, regulation, or court decision,” 21

C.F.R. § 808.1(b), a state may not establish a requirement

that relates to the safety and effectiveness of a device

which is different from or in addition to those require-

ments found in the MDA. The Court must therefore

determine (1) whether federal regulations or statutes

a |

App. 13

exist which set forth requirements which pertain to con-

tact lens solution;! (2) whether the state law claims

asserted in plaintiff’s complaint create requirements

which are in addition to or different from the federal

requirements; and (3) whether the state law relates to the

safety or effectiveness of the contact solution or to “any

other matter included in a requirement” which applies to

the solution under the MDA. 21 U.S.C. § 360k(a); Hun-

saker v. Surgidev Corp., 818 F. Supp. 744, 751 (M.D. Pa.

1992).

In this case, the relevant requirements that are appli-

cable to contact lens solution, in addition to the PMA

process itself, are set forth in 21 C.FR. §§ 800.10 and

800.12. These sections outline the requirements for con-

tact lens solution sterility, and tamper-resistant packaging

and labeling. The regulation dealing with contact lens

! In making such a determination, the Court is mindful that

the regulatory language accompanying the statute makes it

clear that “[t]he FDA did not intend to preempt all state laws

and regulations pertaining to [contact lens disinfectant solu-

tions].” Moore v. Kimberly-Clark Corp., 867 F.2d 243, 244 (5th Cir.

1989). Section 801.1(d) provides that, “[s]tate or local require-

ments are preempted only when the Food and Drug Adminis-

tration has established specific counterpart regulations or there

are other specific requirements applicable to a particular device

under the act....” 21 C.F.R. § 801(d). Courts have interpreted

the statutory and regulatory language to limit the scope of

preemption “to instances where there are specific FDA require-

ments applicable to a particular device or class of devices... .

The phrase ‘or in addition to any requirements applicable under

this Act to the device’ means that an FDA requirement must

exist before preemption can occur.” Rinehart v. International

Playtex, Inc., 688 F. Supp. 475, 478 (S.D. Ind. 1988) (quoting 43

Fed. Reg. 18,662 (1978)).

App. 14

sterility states the solution should be sterile and “of such

purity and quality as to be suitable for safe use in the

eye.” 21 C.F.R. § 800.10(a)(1). This section also details the

packaging requirements to protect the sterility of the

solution and the warning requirements for minimizing

“the hazard of injury resulting from contamination dur-

ing use.” 21 C.F.R. § 800.10(c). The regulation dealing

with tamper resistant packaging and labeling details the

standard packaging for such solutions and the labeling

requirements for notifying the public of such packaging.

21 C.F.R. §§ 800.12(b) and 800.12(c). Clearly these sections

set forth requirements which pertain to contact lens solu-

tion, thereby fulfilling the first condition of preemption.

The second and third conditions of preemption, that

the state law creates a requirement which relates to the

safety and effectiveness of the solution and which adds to

or is different from the federal requirements, are also

satisfied. In his complaint, plaintiff asserts a strict lia-

bility claim based on defective design and manufacturing

of the contact lens solution. Plaintiff also claims defen-

dant was negligent in several respects, including negli-

gent design, production and manufacturing, failure to

properly inspect, and failure to adequately label. Finally,

plaintiff asserts that defendant breached express and

implied warranties. Although no case law exists which

directly address this issue with respect to these particular

sections, the Court finds the regulations are sufficiently

broad in scope to apply to the allegations in plaintiff's

complaint.

Essentially, plaintiff asserts claims similar to those in

Covey v. Surgidev Corp., 815 F. Supp. 1089 (N.D. Ohio

1993). In Covey, the plaintiff asserted that the defendant

App. 15

manufacturer was “liable strictly for negligence for its

faulty design of lens, its failure to warn consumers, and

its inadequate testing of the device.” Id. at 1095. In dis-

missing the complaint, the court stated that “[s]uch

claims, which deal directly with the safety and effective-

ness of the device, are clearly preempted because they

would require practices different from those imposed

under the regulations.” Id. Likewise, in this case, plain-

tiff’s negligence, strict liability, and warranty claims

directly deal with the safety and effectiveness of the

solution and also would require practices different from,

or in addition to, those imposed by the regulations.

Therefore, the plaintiff's claims are preempted.

The Court’s conclusion in this case is also supported

by several cases which address the preemptive scope of

section 360k as it relates to other Class III medical

devices. In the great majority of those cases, the courts

have found that section 360k preempts state requirements

which relate to health and safety. For Example, in Stamps

v. Collagen Corp., 984 F.2d 1416, 1421 (5th Cir.), 114 S. Ct.

86, 126 L. Ed. 2d 54 (1993), the Fifth Circuit interpreted

the language of section 360k to preempt a state tort cause

of action if it “(1) constitutes a requirement different

from, or in addition to, any requirement the MDA makes

applicable to the device at issue and (2) relates either to

(a) the safety or effectiveness of the device or (b) any

other matter included in a requirement made applicable

to the device by the MDA.” In applying this test to the

Class III anti-wrinkle cream in Stamps, the Court held that

the state tort causes of action asserted in that case were

preempted because they constituted requirements that

App. 16

were “either different from or in addition to, a require-

ment - the Class III PMA process - that the MDA has

made applicable to” the anti-wrinkle cream, and because

the state law claims “undoubtedly” related to “either the

safety or effectiveness of zyderm and zyplast, or to some

other matter included in the PMA requirements applica-

ble to the products.” Id. at 1422. See also King v. Collagen

Corp., 983 F.2d 1130 (1st Cir.), cert. denied, 114 S. Ct. 84,

126 L. Ed. 2d 52 (holding plaintiff's state common law

causes of action against collagen manufacturer based on

failure to warn, strict liability, breach of express and

implied warranty, negligence, product misbranding, mis-

representation failure to warn, and fraud were all pre-

empted because allowing such claims would impose

additional or different requirements from the MDA);

Slater v. Optical Radiation Corp., 961 F.2d 1330 (7th Cir.),

cert. denied, 113 S. Ct. 327, 121 L. Ed. 2d 245 (1992)

(holding that the MDA preempted plaintiff’s causes of

action against intraocular lens manufacturer based on

negligence, strict liability, and breach of implied war-

ranty).

This case is not one where plaintiff alleges defendant

failed to comply with its own FDA regulations. Reiter v.

Zimmer, Inc., 830 F. Supp. 199, 203 (S.D.N.Y. 1993). Nor is

it a case where the FDA has failed to issue regulations

which relate to the particular device in question. Moore v.

Kimberly-Clark Corp., 867 F.2d 243, 246 (5th Cir. 1989).

Rather, this case is one where plaintiff asserts causes of

action which relate to the safety or effectiveness of Class

III medical device and which would force defendant to

act different from the requirements imposed by the fed-

eral regulations. Clearly these type of requirements are

App. 17

exactly the kind Congress intended to preempt. There-

fore, defendant’s motion will be granted. A separate

order in accordance with this memorandum opinion will

be entered herein.

DATED this 21st day of December, 1993.

BY THE COURT:

/s/ Lyle E. Strom

LYLE E. STROM, Chief Judge

United States District Court

App. 18

UNITED STATES COURT OF APPEALS

FOR THE EIGHTH CIRCUIT

No. 94-1206NEO

Subby Martello, °

Appellant, * Appeal from the

V. ° United States

* District Court for

, the District of

* Nebraska

Appellee. ‘

Ciba Vision Corporation,

A Georgia Corporation,

(Filed Jan. 9, 1995)

Appellant’s motion for extension of time to file peti-

tion for rehearing has been considered by the Court and

is granted. Appellant may have to 1/17/95 to file the

petition for rehearing.

January 5, 1995

Order entered at the Direction of The Court

/s/ Michael E. Gans

Clerk, U.S. Court of Appeals, Eighth Circuit

App. 19

UNITED STATES COURT OF APPEALS

FOR THE EIGHTH CIRCUIT

U.S. COURT & CUSTOM HOUSE

1114 MARKET STREET

ST. LOUIS, MISSOURI 63101

MICHAEL E. GANS TELEPHONE

Clerk of Court (314) 539-3600

February 7, 1995

Mr. John P. Inserra

INSERRA LAW OFFICES

Sunset Valley Law Building

2580 S. 90th Street

Omaha, NE 68124

RE: 94-1206NEO Subby Martello vs. Ciba Vision

Corp.

Deal Counsel:

Enclosed is a copy of an order entered today in the

above case at the direction of the court.

Sincerely,

/s/ Michael E. Gans

Michael E. Gans

Clerk of Court

mam

Enclosure(s)

cc: Hon. Lyle E. Strom

William J. Brennan Jr.

Gerald L. Friedrichsen

James Welsh

District Court/Agency Case Number(s):

8:CV91-00121

App. 20

UNITED STATES COURT OF APPEALS

FOR THE EIGHTH CIRCUIT

No. 94-1206NEO

Subby Martello, ’

* Appeal from the United

* States District Court for

V. * the District of Nebraska

Appellant,

CIBA Vision Corporation,

A Georgia Corporation, (Filed Feb. 7, 1994)

Appellee. .

The petition for rehearing filed by the appellant has

been considered by the court and is denied.

February 7, 1995

Order Entered at the Direction of the Court:

/s/ Michael E. Gans

Clerk, U.S. Court of Appeals, Eighth Circuit

App. 21

21 U.S.C. Section 360k:

“(a) Except as provided in subsection

(b), ... no state or political subdivision of a state

may establish or continue in effect with respect

to a device intended for human use any require-

ment —

‘(1) which is different from, or in addition

to, any requirement applicable under this

chapter to the device, and

(2) which relates to the safety or effective-

ness of the device or to any other matter

included in a requirement applicable to the

device under this chapter.’”

21 USCA 360c Classification of devices intended for

human use

(a) Classes of devices

(1) There are established the following

classes of devices intended for human use:

(A) Class I, General Controls

(i) A device for which the controls authorized

by or under section 351, 352, 360, 360f, 360h,

360i, or 360j of this title or any combination of

such sections are sufficient to provide reason-

able assurance of the safety and effectiveness of

the device.

(ii) A device for which insufficient information

exists to determine that the controls referred to

in clause (i) are sufficient to provide reasonable

assurance of the safety and effectiveness of the

device or to establish special controls to provide

such assurance, but because it —

App. 22

(I) is not purported or represented to be for a use in

supporting or sustaining human life or for a use which is

of substantial importance in preventing impairment of

human health, and

(II) does not present a potential unreasonable risk

of illness or injury,

is to be regulated by the controls referred to in clause

(i).

(B) Class II, Special Controls

A device which cannot be classified as a class |

device because the general controls by themselves are

insufficient to provide reasonable assurance of the safety

and effectiveness of the device, and for which there is

sufficient information to establish special controls to pro-

vide such assurance, including the promulgation of per-

formance standards, postmarket surveillance, patient

registries, development and dissemination of guidelines

(including guidelines for the submission of clinical data

in premarket notification submissions in accordance with

section 360(k) of this title), recommendations, and other

appropriate actions as the Secretary deems necessary to

provide such assurance. For a device that is purported or

represented to be for a use in supporting or sustaining

human life, the Secretary shall examine and identify the

special controls, if any, that are necessary to provide

adequate assurance of safety and effectiveness and

describe how such controls provide such assurance.

A device which because -

(i) it (I) cannot be classified as a class I device

because insufficient information exists to determine that

App. 23

the application of general controls are sufficient to pro-

vide reasonable assurance of the safety and effectiveness

of the device, and (II) cannot be classified as a class Il

device because insufficient information exists to deter-

mine that the special controls described in subparagraph

(B) would provide reasonable assurance of its safety and

effectiveness, and

(ii)(I) is purported or represented to be for a use in

supporting or sustaining human life or for a use which is

of substantial importance in preventing impairment of

human health, or

(II) presents a potential unreasonable risk of illness

or injury,

is to be subject, in accordance with section 360e of

this title, to premarket approval to provide reasonable

assurance of its safety and effectiveness.

If there is not sufficient information to establish a perfor-

mance standard for a device to provide reasonable assur-

ance of its safety and effectiveness, the Secretary may

conduct such activities as may be necessary to develop or

obtain such information.

(2) For purposes of this section and sections 360d

and 360e of this title, the safety and effectiveness of a

device are to be determined -

(A) with respect to the persons for whose use the

device is represented or intended,

(B) with respect to the conditions of use prescribed,

recommended, or suggested in the labeling of the device,

and

App. 24

the use of the device against any probable risk of injury

or illness from such use.

(3)(A) Except as authorized by subparagraph (B),

the effectiveness of a device is, for purposes of this sec-

tion and sections 360d and 360e of this title, to be deter-

mined, in accordance with regulations promulgated by

the Secretary, on the basis of well-controlled investiga-

tions, including clinical investigations where appropriate,

by experts qualified by training and experience to evalu-

ate the effectiveness of the device, from which investiga-

tions it can fairly and responsibly be concluded by

qualified experts that the device will have the effect it

purports or is represented to have under the conditions

of use prescribed, recommended, or suggested in the

labeling of the device.

(B) If the Secretary determines that there exists

valid scientific evidence (other than evidence derived

from investigations described in subparagraph (A) ) -

(i) which is sufficient to determine the effectiveness

of a device, and

(ii) from which it can fairly and responsibly be con-

cluded by qualified experts that the device will have the

effect it purports or is represented to have under the

conditions of use prescribed, recommended, or suggested

in the labeling of the device,

then, for purposes of this section and sections 360d and

360e of this title, the Secretary may authorize the effec-

tiveness of the device to be determined on the basis of

such evidence.

App. 25

(b) Classification panels

(1) For purposes of -

(A) determining which devices intended for human

use should be subject to the requirements of general

controls, performance standards, or premarket approval,

and

(B) providing notice to the manufacturers and

importers of such devices to enable them to prepare for

the application of such requirements to devices manufac-

tured or imported by them,

the Secretary shall classify all such devices (other than

devices classified by subsection (f) of this section) into the

classes established by subsection (a) of this section. For

the purpose of securing recommendations with respect to

the classification of devices, the Secretary shall establish

panels of experts or use panels of experts established

before May 28, 1976, or both. Section 14 of the Federal

Advisory Committee Act shall not apply to the duration

of a panel established under this paragraph.

(2) The Secretary shall appoint to each panel estab-

lished under paragraph (1) persons who are qualified by

training and experience to evaluate the safety and effec-

tiveness of the devices to be referred to the panel and

who, to the extent feasible, possess skill in the use of, or

experience in the development, manufacture, or utiliza-

tion of, such devices. The Secretary shall make appoint-

ments to each panel so that each panel shall consist of

members with adequately diversified expertise in such

fields as clinical and administrative medicine, engineer-

ing, biological and physical sciences, and other related

App. 26

professions. In addition, each panel shall include as non-

voting members a representative of consumer interests

and a representative of interests of the device manufac-

turing industry. Scientific, trade, and consumer organiza-

tions shall be afforded an opportunity to nominate

individuals for appointment to the panels. No individual

who is in the regular full-time employ of the United

States and engaged in the administration of this chapter

may be a member of any panel. The Secretary shall desig-

nate one of the members of each panel to serve as chair-

man thereof.

(3) Panel members (other than officers or employees

of the United States), while attending meetings or confer-

ences of a panel or otherwise engaged in its business,

shall be entitled to receive compensation at rates to be

fixed by the Secretary, but not at rates exceeding the daily

equivalent of the rate in effect for grade GS-18 of the

General Schedule, for each day so engaged, including

travel time; and while so serving away from their homes

or regular places of business each member may be

allowed travel expenses (including per diem in lieu of

subsistence) as authorized by section 5703 of Title 5, for

persons in the Government service employed intermit-

tently.

(4) The Secretary shall furnish each panel with ade-

quate clerical and other necessary assistance.

(1) The Secretary shall organize the panels accord-

ing to the various fields of clinical medicine and funda-

mental sciences in which devices intended for human use

App. 27

are used. The Secretary shall refer a device to be classi-

fied under this section to an appropriate panel estab-

lished or authorized to be used under subsection (b) of

this section for its review and for its recommendation

respecting the classification of the device. The Secretary

shall by regulation prescribe the procedure to be followed

by the panels in making their reviews and recommenda-

tions. In making their reviews of devices, the panels, to

the maximum extent practicable, shall provide an oppor-

tunity for interested persons to submit data and views on

the classification of the devices.

(2)(A) Upon completion of a panel’s review of a

device referred to it under paragraph (1), the panel shall,

subject to subparagraphs (B) and (C), submit to the Secre-

tary its recommendation for the classification of the

device. Any such recommendation shall (i) contain (I) a

summary of the reasons for the recommendation, (II) a

summary of the data upon which the recommendation is

based, and (III) an identification of the risks to health (if

any) presented by the device with respect to which the

recommendation is made, and (ii) to the extent practica-

ble, include a recommendation for the assignment of a

priority for the application of the requirements of section

360d or 360e of this title to a device recommended to be

classified in class II or class III.

(B) A recommendation of a panel for the classifica-

tion of a device in class I shall include a recommendation

as to whether the device should be exempted from the

requirements of section 360, 360i, or 360j(f) of this title.

under paragraph (1) to a panel, and which -

App. 28

(i) is intended to be implanted in the human body

or is purported or represented to be for a use in support-

ing or sustaining human life, and

(ii)(1) has been introduced or delivered for intro-

duction into interstate commerce for commercial distribu-

tion before May 28, 1976, or

(II) is within a type of device which was so intro-

duced or delivered before such date and is substantially

equivalent to another device within that type,

such panel shall recommend to the Secretary that the

device be classified in class Ili unless the panel deter-

mines that classification of the device in such class is not

necessary to provide reasonable assurance of its safety

and effectiveness. If a panel does not recommend that

such a device be classified in class III, it shall in its

recommendation to the Secretary for the classification of

the device set forth the reasons for not recommending

classification of the device in such class.

(3) The panels shall submit to the Secretary within

one year of the date funds are first appropriated for the

implementation of this section their recommendations

respecting all devices of a type introduced or delivered

for introduction into interstate commerce for commercial

distribution before May 28, 1976.

(d) Panel recommendation; publication; priorities

(1) Upon receipt of a recommendation from a panel

respecting a device, the Secretary shall publish in the

Federal Register the panel’s recommendation and a pro-

posed regulation classifying such device and shall pro-

vide interested persons an opportunity to submit

App. 29

comments on such recommendation and the proposed

regulation. After reviewing such comments, the Secretary

shall, subject to paragraph (2), by regulation classify such

device.

(2)(A) A regulation under paragraph (1) classifying

a device in class I shall prescribe which, if any, of the

requirements of section 360, 360i, or 360j(f) of this title

shall not apply to the device. A regulation which makes a

requirement of section 360, 360i, or 360j(f) of this title

inapplicable to a device shall be accompanied by a state-

ment of the reasons of the Secretary for making such

requirement inapplicable.

(B) A device described in subsection (c) (2) (C) of

this section shall be classified in class III unless the Secre-

tary determines that classification of the device in such

class is not necessary to provide reasonable assurance of

its safety and effectiveness. A proposed regulation under

paragraph (1) classifying such a device in a class other

than class III shall be accompanied by a full statement of

the reasons of the Secretary (and supporting documenta-

tion and data) for not classifying such device in such

class and an identification of the risks to health (if any)

presented by such device.

(3) In the case of devices classified in class II and

devices classified under this subsection in class III and

described in section 360e(b) (1) of this title the Secretary

may establish priorities which, in his discretion, shall be

used in applying sections 360d and 360e of this title, as

appropriate, to such devices.

App. 30

(e) Classification changes

(1) Based on new information respecting a device,

the Secretary may, upon his own initiative or upon peti-

tion of an interested person, by regulation (A) change

such device’s classification, and (B) revoke, because of

the change in classification, any regulation or require-

ment in effect under section 360d or 360e of this title with

respect to such device. In the promulgation of such a

regulation respecting a device’s classification, the Secre-

tary may secure from the panel to which the device was

last referred pursuant to subsection (c) of this section a

recommendation respecting the proposed change in the

device’s classification and shall publish in the Federal

by the panel respecting such change. A regulation under

this subsection changing the classification of a device

from class III to class II may provide that such classifica-

tion shall not take effect until the effective date of a

performance standard established under section 360d of

this title for such device.

(2) By regulation promulgated under paragraph (1),

the Secretary may change the classification of a device

from class III -

(A) to class II if the Secretary determines that spe-

cial controls would provide reasonable assurance of the

safety and effectiveness of the device and that general

controls would not provide reasonable assurance of the

safety and effectiveness of the device, or

(B) to class lif the Secretary determines that general

controls would provide reasonable assurance of the

safety and effectiveness of the device.

App. 31

(f) Initial classification and reclassification of certain

devices

(1) Any device intended for human use which was

not introduced or delivered for introduction into inter-

state commerce for commercial distribution before May

28, 1976, is classified in class III unless -

(A) the device -

(i) is within a type of device (I) which was intro-

duced or delivered for introduction into interstate com-

merce for commercial distribution before such date and

which is to be classified pursuant to subsection (b) of this

section, or (II) which was not so introduced or delivered

before such date and has been classified in class I or II,

and

(ii) is substantially equivalent to another device

within such type, or

(B) the Secretary in response to a petition submitted

under paragraph (2) has classified such device in class I

or Il.

A device classified in class III under this paragraph shall

be classified in that class until the effective date of an

order of the Secretary under paragraph (2) classifying the

device in class I or II.

(2)(A) The Secretary may initiate the reclassification

of a device classified into class III] under paragraph (1) of

this subsection or the manufacturer or importer of a

device classified under paragraph (1) may petition the

Secretary (in such form and manner as he shall prescribe)

for the issuance of an order classifying the device in class

I or class II]. Within thirty days of the filing of such a

App. 32

petition, the Secretary shall notify the petitioner of any

deficiencies in the petition which prevent the Secretary

from making a decision on the petition.

(B)(i) Upon determining that a petition does not

contain any deficiency which prevents the Secretary from

making a decision on the petition, the Secretary may for

good cause shown refer the petition to an appropriate

panel established or authorized to be used under subsec-

tion (b) of this section. A panel to which such a petition

has been referred shall not later than ninety days after the

referral of the petition make a recommendation to the

Secretary respecting approval or denial of the petition.

Any such recommendation shall contain (I) a summary of

the reasons for the recommendation, (II) a summary of

the data upon which the recommendation is based, and

(III) an identification of the risks to health (if any) pre-

sented by the device with respect to which the petition

was filed. In the case of a petition for a device which is

intended to be implanted in the human body or which is

purported or represented to be for a use in supporting or

sustaining human life, the panel shall recommend that

the petition be denied unless the panel determines that

the classification in class III of the device is not necessary

to provide reasonable assurance of its safety and effec-

tiveness. If the panel recommends that such petition be

approved, it shall in its recommendation to the Secretary

set forth its reasons for such recommendation.

(ii) The requirements of paragraphs (1) and (2) of

subsection (c) of this section (relating to opportunities for

submission of data and views and recommendations

respecting priorities and exemptions from sections 360,

360i, and 360j(f) of this title) shall apply with respect to

App. 33

consideration by panels of petitions submitted under sub-

paragraph (A).

(C)(i) Within ninety days from the date the Secre-

tary receives the recommendation of a panel respecting a

petition (but not later than 210 days after the filing of

such petition) the Secretary shall by order deny or

approve the petition. If the Secretary approves the peti-

tion, the Secretary shall order the classification of the

device into class I or class II in accordance with the

criteria prescribed by subsection (a) (1) (A) or (a) (1) (B)

of this section. In the case of a petition for a device which

is intended to be implanted in the human body or which

is purported or represented to be for a use in supporting

or sustaining human life, the Secretary shall deny the

petition unless the Secretary determines that the classi-

fication in class III of the device is not necessary to

provide reasonable assurance of its safety and effective-

ness. An order approving such petition shall be accom-

panied by a full statement of the reasons of the Secretary

(and supporting documentation and data) for approving

the petition and an identification of the risks to health (if

any) presented by the device to which such order applies.

(ii) The requirements of paragraphs (1) and (2) (A)

of subsection (d) of this section (relating to publication of

recommendations, opportunity for submission of com-

ments, and exemption from sections 360, 360i, and 360j(f)

of this title) shall apply with respect to action by the

Secretary on petitions submitted under subparagraph

(A).

App. 34

(3) If a manufacturer reports to the Secretary under

section 360(k) of this title that a device is substantially

equivalent to another device -

(A) which the Secretary has classified as a class II]

device under subsection (b) of this section,

(B) which was introduced or delivered for introduc-

tion into interstate commerce for commercial distribution

before December 1, 1990, and

market approval has been promulgated under section

360e(b) of this title,

the manufacturer shall certify to the Secretary that the

manufacturer has conducted a reasonable search of all

information known or otherwise available to the manu-

facturer respecting such other device and has included in

the report under section 360(k) of this title a summary of

and a citation to all adverse safety and effectiveness data

respecting such other device and respecting the device

for which the section 360(k) report is being made and

which has not been submitted to the Secretary under

section 360i of this title. The Secretary may require the

manufacturer to submit the adverse safety and effective-

ness data described in the report.

(g) Information

Within sixty days of the receipt of a written request

of any person for information respecting the class in

which a device has been classified or the requirements

applicable to a device under this chapter, the Secretary

shall provide such person a written statement of the

a eT ee. eT

App. 35

classification (if any) of such device and the requirements

of this chapter applicable to the device.

(h) Definitions

For purposes of this section and sections 351, 360,

360d, 360e, 360f, 360i, and 360j of this title

(1) a reference to “general controls” is a reference to

the controls authorized by or under sections 351, 352, 360,

360f, 360h, 360i, and 360j of this title,

(2) areference to “class I”, “class II”, or “class III” is

a reference to a class of medical devices described in

subparagraph (A), (B), or (C) of subsection (a) (1) of this

section, and

(3) a reference to a “panel under section 360c of this

title” is a reference to a panel established or authorized to

be used under this section.

(i) Substantial equivalence

(1)(A) For purposes of determinations of substantial

equivalence under subsection (f) of this section and section

360j(1) of this title, the term “substantially equivalent” or

“substantial equivalence” means, with respect to a device

being compared to a predicate device, that the device has the

same intended use as the predicate device and that the

Secretary by order has found that the device -

(i) has the same technological characteristics as the

predicate device, or

(ii)(I) has different technological characteristics and

the information submitted that the device is substantially

equivalent to the predicate device contains information,

App. 36

including clinical data if deemed necessary by the Secre-

tary, that demonstrates that the device is as safe and

effective as a legally marketed device, and (II) does not

raise different questions of safety and efficacy than the

predicate device.

(B) For purposes of subparagraph (A), the term

“different technological characteristics” means, with

respect to a device being compared to a predicate device,

that there is a significant change in the materials, design,

energy source, or other features of the device from those

of the predicate device.

(2) A device may not be found to be substantially

equivalent to a predicate device that has been removed

from the market at the initiative of the Secretary or that

has been determined to be misbranded or adulterated by

a judicial order.

(3)(A) As part of a submission under section 36()(k)

of this title respecting a device, the person required to file

a premarket notification under such section shall provide

an adequate summary of any information respecting

safety and effectiveness or state that such information

will be made available upon request by any person.

(B) Any summary under subparagraph (A) respect-

ing a device shall contain detailed information regarding

data concerning adverse health effects and shail be made

available to the public by the Secretary within 30 days of

the issuance of a determination that such device is sub-

stantially equivalent to another device.

App. 37

21 USCA 360e :

(a) General requirement

A class III device -

(1) which is subject to a regulation promulgated

under subsection (b) of this section; or

(2) which is a class III device because of section

360c(f) of this title,

is required to have, unless exempt under section 360j(g)

of this title, an approval under this section of an applica-

tion for premarket approval.

(b) Regulation to require premarket approval

(1) In the case of a class III device which -

(A) was introduced or delivered for introduction

into interstate commerce for commercial distribution

before May 28, 1976; or

(B) is (i) of a type so introduced or delivered, and

(ii) is substantially equivalent to another device within

that type,

the Secretary shall by regulation, promulgated in accor-

dance with this subsection, require that such device have

an approval under this section of an application for pre-

market approval.

(2)(A) <A proceeding for the promulgation of a regula-

tion under paragraph (1) respecting a device shall be initi-

ated by the publication in the Federal Register of a notice of

proposed rule making. Such notice shall contain -

App. 38

(i) the proposed regulation;

(ii) proposed findings with respect to the degree of

risk of illness or injury designed to be eliminated or

reduced by requiring the device to have an approved

application for premarket approval and the benefit to the

public from use of the device;

(iii) opportunity for the submission of comments on

the proposed regulation and the proposed findings; and

(iv) opportunity to request a change in the classi-

fication of the device based on new information relevant

to the classification of the device.

(B) If, within fifteen days after publication of a

notice under subparagraph (A), the Secretary receives a

request for a change in the classification of a device, he

shall, within sixty days of the publication of such notice

and after consultation with the appropriate panel under

section 360c of this title, by order published in the Fed-

eral Register, either deny the request for change in classi-

fication or give notice of his intent to initiate such a

change under section 360c(e) of this title.

(3) After the expiration of the period for comment

on a proposed regulation and proposed findings pub-

lished under paragraph (2) and after consideration of

comments submitted on such proposed regulation and

findings, the Secretary shall (A) promulgate such regula-

tion and publish in the Federal Register findings on the

matters referred to in paragraph (2) (A) (ii), or (B) publish

a notice terminating the proceeding for the promulgation

App. 39

of the regulation together with the reasons for such termi-

nation. If a notice of termination is published, the Secre-

tary shall (unless such notice is issued because the device

is a banned device under section 360f of this title) initiate

a proceeding under section 360c(e) of this title to

reclassify the device subject to the proceeding terminated

by such notice.

(4) The Secretary, upon his own initiative or upon

petition of an interested person, may by regulation

amend or revoke any regulation promulgated under this

subsection. A regulation to amend or revoke a regulation

under this subsection shall be promulgated in accordance

with the requirements prescribed by this subsection for

the promulgation of the regulation to be amended or

revoked.

(1) Any person may file with the Secretary an appli-

cation for premarket approval for a class III device. Such

an application for a device shall contain -

(A) full reports of all information, published or

known to or which should reasonably be known to the

applicant, concerning investigations which have been

made to show whether or not such device is safe and

effective;

(B) a full statement of the components, ingredients,

and properties and of the principle or principles of opera-

tion, of such device;

App. 40

the facilities and controls used for, the manufacture, pro-

cessing, and, when relevant, packing and installation of,

such device;

(D) an identifying reference to any performance

standard under section 360d of this title which would be

applicable to any aspect of such device if it were a class II

device, and either adequate information to show that

such aspect of such device fully meets such performance

standard or adequate information to justify any deviation

from such standard;

(E) such samples of such device and of components

thereof as the Secretary may reasonably require, except

that where the submission of such samples is impractica-

ble or unduly burdensome, the requirement of this sub-

paragraph may be met by the submission of complete

information concerning the location of one or more such

devices readily available for examination and testing;

(F) specimens of the labeling proposed to be used

for such device; and

(G) such other information relevant to the subject

matter of the application as the Secretary, with the con-

currence of the appropriate panel under section 360c of

this title, may require.

(2) Upon receipt of an application meeting the

requirements set forth in paragraph (1), the Secretary -

(A) may on the Secretary’s own initiative, or

(B) shall, upon the request of an applicant unless

the Secretary finds that the information in the application

App. 41

which would be reviewed by a panel substantially dupli-

cates information which has previously been reviewed by

a panel appointed under section 360c of this title,

refer such application to the appropriate panel under

section 360c of this title for study and for submission

(within such period as he may establish) of a report and

recommendation respecting approval of the application,

together with all underlying data and the reasons or basis

for the recommendation.

(d) Action on application for premarket approval

(1)(A) As promptly as possible, but in no event later

than one hundred and eighty days after the receipt of an

application under subsection (c) of this section (except as

provided in section 360j(1) (3) (D) (ii) of this title or

unless, in accordance with subparagraph (B) (i), an addi-

tional period as agreed upon by the Secretary and the

applicant), the Secretary, after considering the report and

recommendation submitted under paragraph (2) of such

subsection, shall —

(i) issue an order approving the application if he

finds that none of the grounds for denying approval

specified in paragraph (2) of this subsection applies; or

(ii) deny approval of the application if he finds (and

sets forth the basis for such finding as part of or accom-

panying such denial) that one or more grounds for denial

specified in paragraph (2) of this subsection apply.

(B)(i) The Secretary may not enter into an agree-

ment to extend the period in which to take action with

respect to an application submitted for a device subject to

a regulation promulgated under subsection (b) of this

App. 42

section unless he finds that the continued availability of

the device is necessary for the public health.

(ii) An order approving an application for a device

may require as a condition to such approval that the sale

and distribution of the device be restricted but only to the

extent that the sale and distribution of a device may be

restricted under a regulation under section 360j(e) of this

title.

(2) The Secretary shall deny approval of an applica-

tion for a device if, upon the basis of the information

submitted to the Secretary as part of the application and

any other information before him with respect to such

device, the Secretary finds that -

(A) there is a lack of a showing of reasonable assur-

ance that such device is safe under the conditions of use

prescribed, recommended, or suggested in the proposed

labeling thereof;

(B) there is a lack of a showing of reasonable assur-

ance that the device is effective under the conditions of

use prescribed, recommended, or suggested in the pro-

posed labeling thereof;

used for, the manufacture, processing, packing, or instal-

lation of such device do not conform to the requirements

of section 360j(f) of this title;

(D) based on a fair evaluation of all material facts,

the proposed labeling is false or misleading in any partic-

ular; or

(E) such device is not shown to conform in all

respects to a performance standard in effect under section

App. 43

360d of this title compliance with which is a condition to

approval of the application and there is a lack of ade-

quate information to justify the deviation from such stan-

dard.

Any denial of an application shall, insofar as the Secre-

tary determines to be practicable, e accompanied by a

statement informing the applicant of the measures

required to place such application in approvable form

(which measures may include further research by the

applicant in accordance with one or more protocols pre-

scribed by the Secretary).

(3) An applicant whose application has been denied

approval may, by petition filed on or before the thirtieth

day after the date upon which he receives notice of such

denial, obtain review thereof in accordance with either

paragraph (1) or (2) of subsection (g) of this section, and

any interested person may obtain review, in accordance

with paragraph (1) or (2) of subsection (g) of this section,

of an order of the Secretary approving an application.

(e) Withdrawal and temporary suspension of approval

of application for premarket approval

(1) The Secretary shall, upon obtaining, where

appropriate, advice on scientific matters from a panel or

panels under section 360c of this title, and after due

notice and opportunity for informa! hearing to the holder

of an approved application for a device, issue an order

withdrawing approval of the application if the Secretary

finds -

App. 44

(A) that such device is unsafe or ineffective under

the conditions of use prescribed, recommended, or sug-

gested in the labeling thereof;

(B) onthe basis of new information before him with

respect to such device, evaluated together with the evi-

dence available to him when the application was

approved, that there is a lack of a showing of reasonable

assurance that the device is safe or effective under the

conditions of use prescribed, recommended, or suggested

in the labeling thereof;

panied by an untrue statement of a material fact;

(D) that the applicant (i) has failed to establish a

system for maintaining records, or has repeatedly or

deliberately failed to maintain records or to make reports,

required by an applicable regulation under section 360i(a)

of this title, (ii) has refused to permit access to, or copy-

ing or verification of, such records as required by section

374 of this title, or (iii) has not complied with the require-

ments of section 360 of this title;

(E) onthe basis of new information before him with

respect to such device, evaluated together with the evi-

dence before him when the application was approved,

that the methods used in, or the facilities and controls

used for, the manufacture, processing, packing, or instal-

lation of such device do not conform with the require-

ments of section 360j(f) of this title and were not brought

into conformity with such requirements within a reason-

able time after receipt of written notice from the Secretary

of nonconformity;

App. 45

(F) on the basis of new information before him,

evaluated together with the evidence before him when

the application was approved, that the labeling of such

device, based on a fair evaluation of all material facts, is

false or misleading in any particular and was not cor-

rected within a reasonable time after receipt of written

notice from the Secretary of such fact; or

(G) on the basis of new information before him,

evaluated together with the evidence before him when

the application was approved, that such device is not

shown to conform in all respects to a performance stan-

dard which is in effect under section 360d of this title

compliance with which was a condition to approval of the

application and that there is a lack of adequate informa-

tion to justify the deviation from such standard.

(2) The holder of an application subject to an order

issued under paragraph (1) withdrawing approval of the

application may, by petition filed on or before the thir-

tieth day after the date upon which he receives notice of

such withdrawal, obtain review thereof in accordance

with either paragraph (1) or (2) of subsection (g) of this

section.

(3) If, after providing an opportunity for an infor-

mal hearing, the Secretary determines there is reasonable

probability that the continuation of distribution of a

device under an approved application would cause

serious, adverse health consequences or death, the Secre-

tary shall by order temporarily suspend the approval of

the application approved under this section. If the Secre-

tary issues such an order, the Secretary shall proceed

a as eeraeetnn

an na ne ere mans ve oo =o Naga

App. 46

expeditiously under paragraph (1) to withdraw such

application.

(f) Product development protocol

(1) In the case of a class III device which is required

to have an approval of an application submitted under

subsection (c) of this section, such device shall be consid-

ered as having such an approval if a notice of completion

of testing conducted in accordance with a product devel-

opment protocol approved under paragraph (4) has been

declared completed under paragraph (6).

(2) Any person may submit to the Secretary a pro-

posed product development protocol with respect to a

device. Such a protocol shall be accompanied by data

supporting it. If, within thirty days of the receipt of such

a protocol, the Secretary determines that it appears to be

appropriate to apply the requirements of this subsection

to the device with respect to which the protocol is sub-

mitted, he shall refer the proposed protocol to the appro-

priate panel under section 360c of this title for its

recommendation respecting approval of the protocol.

(3) A proposed product development protocol for a

device may be approved only if -

(A) the Secretary determines that it is appropriate

to apply the requirements of this subsection to the device

in lieu of the requirement of approval of an application

submitted under subsection (c) of this section; and

(B) the Secretary determines that the proposed pro-

tocol provides -

(i) a description of the device and the changes

which may be made in the device,

App. 47

(ii) a description of the preclinical trials (if any) of

the device and a specification of (I) the results from such

trials to be required before the commencement of clinical

trials of the device, and (II) any permissible variations in

preclinical trials and the results therefrom,

(iii) a description of the clinical trials (if any) of the

device and a specification of (I) the results from such

trials to be required before the filing of a notice of com-

pletion of the requirements of the protocol, and (II) any

permissible variations in such trials and the results there-

from,

(iv) a description of the methods to be used in, and

the facilities and controls to be used for, the manufacture,

processing, and, when relevant, packing and installation

of the device,

(v) an identifying reference to any performance

standard under section 360d of this title to be applicable

to any aspect of such device,

(vi) if appropriate, specimens of the labeling pro-

posed to be used for such device,

(vii) such other information relevant to the subject

matter of the protocol as the Secretary, with the concur-

rence of the appropriate panel or panels under section

360c of this title, may require, and

(viii) a requirement for submission of progress

reports and, when completed, records of the trials con-

ducted under the protocol which records are adequate to

show compliance with the protocol.

(4) The Secretary shall approve or disapprove a pro-

posed product development protocol submitted under

App. 48

paragraph (2) within one hundred and twenty days of its

receipt unless an additional period is agreed upon by the

Secretary and the person who submitted the protocol.

Approval of a protocol or denial of approval of a protocol

is final agency action subject to judicial review under

chapter 7 of Title 5.

(5) At any time after a product development proto-

col for a device has been approved pursuant to paragraph

(4), the person for whom the protocol was approved may

submit a notice of completion -

(A) stating (i) his determination that the require-

ments of the protocol have been fulfilled and that, to the

best of his knowledge, there is no reason bearing on

safety or effectiveness why the notice of completion

should not become effective, and (ii) the data and other

information upon which such determination was made,

and

(B) setting forth the results of the trials required by

the protocol and all the information required by subsec-

tion (c) (1) of this section.

(6)(A) The Secretary may, after providing the per-

son who has an approved protocol an opportunity for an

informal hearing and at any time prior to receipt of notice

of completion of such protocol, issue a final order to

revoke such protocol if he finds that -

(i) such person has failed substantially to comply

with the requirements of the protocol,

(ii) the results of the trials obtained under the pro-

tocol differ so substantially from the results required by

the protocol that further trials cannot be justified, or

App. 49

(iii) the results of the trials conducted under the

protocol or available new information do not demon-

strate that the device tested under the protocol does not

present an unreasonable risk to health and safety.

(B) After the receipt of a notice of completion of an

approved protocol the Secretary shall, within the ninety-

day period beginning on the date such notice is received,

by order either declare the protocol completed or declare

it not completed. An order declaring a protocol not com-

pleted may take effect only after the Secretary has pro-

vided the person who has the protocol opportunity for an

informal hearing on the order. Such an order may be

issued only if the Secretary finds -

(i) such person has failed substantially to comply

with the requirements of the protocol,

(ii) the results of the trials obtained under the pro-

tocol differ substantially from the results required by the

protocol, or

(iii) there is a lack of a showing of reasonable assur-

ance of the safety and effectiveness of the device under

the conditions of use prescribed, recommended, or sug-

gested in the proposed labeling thereof.

(B) shall be in writing and shall contain the reasons to

support the conclusions thereof.

(7) At any time after a notice of completion has

become effective, the Secretary may issue an order (after

due notice and opportunity for an informal hearing to the

person for whom the notice is effective) revoking the

approval of a device provided by a notice of completion

App. 50

which has become effective as provided in subparagraph

(B) if he finds that any of the grounds listed in subpara-

graphs (A) through (G) of subsection (e) (1) of this section

apply. Each reference in such subparagraphs to an appli-

cation shall be considered for purposes of this paragraph

as a reference to a protocol and the notice of completion

of such protocol, and each reference to the time when an

application was approved shall be considered for pur-

poses of this paragraph as a reference to the time when a

notice of completion took effect.

(8) A person who has an approved protocol subject

to an order issued under paragraph (6) (A) revoking such

protocol, a person who has an approved protocol with

respect to which an order under paragraph (6) (B) was

issued declaring that the protocol had not been com-

pleted, or a person subject to an order issued under

paragraph (7) revoking the approval of a device may, by

petition filed on or before the thirtieth day after the date

upon which he receives notice of such order, obtain

review thereof in accordance with either paragraph (1) or

(2) of subsection (g) of this section.

(g) Review

(1) Upon petition for review of -

(A) an order under subsection (d) of this section

approving or denying approval of an application or an

order under subsection (e) of this section withdrawing

approval of an application, or

(B) an order under subsection (f) (6) (A) of this

section revoking an approved protocol, under subsection

(f) (6) (B) of this section declaring that an approved

App. 51

protocol has not been completed, or under subsection (f)

(7) of this section revoking the approval of a device,

the Secretary shall, unless he finds the petition to be

without good cause or unless a petition for review of

such order has been submitted under paragraph (2), hold

a hearing, in accordance with section 554 of Title 5, on the

order. The panel or panels which considered the applica-

tion, protocol, or device subject to such order shall desig-

nate a member to appear and testify at any such hearing

upon request of the Secretary, the petitioner, or the officer

conducting the hearing, but this requirement does not

preclude any other member of the panel or panels from

appearing and testifying at any such hearing. Upon com-

pletion of such hearing and after considering the record

established in such hearing, the Secretary shall issue an

order either affirming the order subject to the hearing or

reversing such order and, as appropriate, approving or

denying approval of the application, reinstating the

application’s approval, approving the protocol, or placing

in effect a notice of completion.

(2)(A) Upon petition for review of -

(i) an order under subsection (d) of this section

approving or denying approval of an application or an

order under subsection (e) of this section withdrawing

approval of an application, or

(ii) an order under subsection (f) (6) (A) of this

section revoking an approved protocol, under subsection

(f) (6) (B) of this section declaring that an approved

protocol has not been completed, or under subsection (f)

(7) of this section revoking the approval of a device,

App. 52

the Secretary shall refer the application or protocol sub-

ject to the order and the basis for the order to an advisory

committee of experts established pursuant to subpara-

graph (B) for a report and recommendation with respect

to the order. The advisory committee shall, after indepen-

dent study of the data and information furnished to it by

the Secretary and other data and information before it,

submit to the Secretary a report and recommendation,

together with al] underlying data and information and a

statement of the reasons or basis for the recommendation.

A copy of such report shall be promptly supplied by the

Secretary to any person who petitioned for such referral

to the advisory committee.

(B) The Secretary shall establish advisory commit-

tees (which may not be panels under section 360c of this

title) to receive referrals under subparagraph (A). The

Secretary shall appoint as members of any such advisory

committee persons qualified in the subject matter to be

referred to the committee and of appropriately diver-

sified professional backgrounds, except that the Secretary

may not appoint to such a committee any individual who

is in the regular full-time employ of the United States and

engaged in the administration of this chapter. Members of

an advisory committee (other than officers or employees

of the United States), while attending conferences or

meetings of their committee or otherwise serving at the

request of the Secretary, shall be entitled to receive com-

pensation at rates to be fixed by the Secretary, which rates

may not exceed the daily equivalent for grade GS-18 of

the General Schedule for each day (including travel time)

they are so engaged; and while so serving away from

their homes or regular places of business each member

App. 53

may be allowed travel expenses, including per diem in

lieu of subsistence, as authorized by section 5703 of Title

5 for persons in the Government service employed inter-

mittently. The Secretary shall designate the chairman of

an advisory committee from its members. The Secretary

shall furnish each advisory committee with clerical and

other assistance, and shall by regulation prescribe the

procedures to be followed by each such committee in

acting on referrals made under subparagraph (A).

recommendation made by an advisory committee with

respect to an application and shall by order, stating the

reasons therefor, either affirm the order referred to the

advisory committee or reverse such order and, if appro-

priate, approve or deny approval of the application, rein-

state the application’s approval, approve the protocol, or

place in effect a notice of completion.

(h) Service of orders

Orders of the Secretary under this section shall be

served (1) in person by any officer or employee of the

department designated by the Secretary, or (2) by mailing

the order by registered mail or certified mail addressed to

the applicant at his last known address in the records of

the Secretary.

(i) Revision

(1) Before December 1, 1995, the Secretary shall by

order require manufacturers of devices, which were intro-

duced or delivered for introduction into interstate com-

merce for commercial distribution before May 28, 1976,

and which are subject to revision of classification under

App. 54

paragraph (2), to submit to the Secretary a summary of

and citation to any information known or otherwise

available to the manufacturer respecting such devices,

including adverse safety or effectiveness information

which has not been submitted under section 360i of this

title. The Secretary may require the manufacturer to sub-

mit the adverse safety or effectiveness data for which a

summary and citation were submitted, if such data are

available to the manufacturer.

(2) After the issuance of an order under paragraph

(1) but before December 1, 1995, the Secretary shall pub-

lish a regulation in the Federal Register for each device -

(A) which the Secretary has classified as a class III

device, and

(B) for which no final regulation has been promul-

gated under subsection (b) of this section,

revising the classification of the device so that the device

is classified into class I or class II, unless the regulation

requires the device to remain in class III. In determining

whether to revise the classification of a device or to

require a device to remain in class III, the Secretary shall

apply the criteria set forth in section 360c(a) of this title.

Before the publication of a regulation requiring a device

to remain in class III or revising its classification, the

Secretary shall publish a proposed regulation respecting

the classification of a device under this paragraph and

provide reasonable opportunity for the submission of

comments on any such regulation. No regulation requir-

ing a device to remain in class III or revising its classifica-

tion may take effect before the expiration of 90 days from

App. 55

the date of its publication in the Federal Register as a

proposed regulation.

(3) The Secretary shall, as promptly as is reasonably

achievable, but not later than 12 months after the effec-

tive date of the regulation requiring a device to remain in

class III, establish a schedule for the promulgation of a

regulation under subsection (b) of this section for each

device which is subject to the regulation requiring the

device to remain in class III.

21 CFR § 814.20 Application.

(a) The applicant or an authorized representative

shall sign the PMA. If the applicant does not reside or

have a place of business within the United States, the

PMA shall be countersigned by an authorized representa-

tive residing or maintaining a place of business in the

United States and shall identify the representative’s name

and address.

(b) Unless the applicant justifies an omission in

accordance with paragraph (d) of this section, a PMA

shall include:

(1) The name and address of the applicant.

(2) A table of contents that specifies the volume and

page number for each item referred to in the table. A

PMA shall include separate sections on nonclinical labo-

ratory studies and on clinical investigations involving

human subjects. A PMA shall be submitted in six copies

each bound in one or more numbered volumes of reason-

able size. The applicant shall include information that it

believes to be trade secret or confidential commercial or

App. 56

financial information in all copies of the PMA and iden-

tify in at least one copy the information that it believes to

be trade secret or confidential commercial or financial

information.

(3) A summary in sufficient detail that the reader

may gain a general understanding of the data and infor-

mation in the application. The summary shall contain the

following information:

(i) Indications for use. A general description of the

disease or condition the device will diagnose, treat, pre-

vent, cure, or mitigate, including a description of the

patient population for which the device is intended.

(ii) Device description. An explanation of how the

device functions, the basic scientific concepts that form

the basis for the device, and the significant physical and

performance characteristics of the device. A brief descrip-

tion of the manufacturing process should be included if it

will significantly enhance the reader’s understanding of

the device. The generic name of the device as well as any

proprietary name or trade name should be included.

(iii) Alternative practices and procedures. A

description of existing alternative practices or procedures

for diagnosing, treating, preventing, curing, or mitigating

the disease or condition for which the device is intended.

(iv) Marketing history. A brief description of the

foreign and U.S. marketing history, if any, of the device,

including a list of all countries in which the device has

been marketed and a list of all countries in which the

device has been withdrawn from marketing for any rea-

son related to the safety or effectiveness of the device.

App. 57

The description shall include the history of the marketing

of the device by the applicant and, if known, the history

of the marketing of the device by any other person.

(v) Summary of studies. An abstract of any informa-

tion or report described in the PMA under paragraph

(b)(8)(ii) of this section and a summary of the results of

technical data submitted under paragraph (b)(6) of this

section. Such summary shall include a description of the

objective of the study, a description of the experimental

design of the study, a brief description of how the data

were collected and analyzed, and a brief description of

the results, whether positive, negative, or inconclusive.

This section shall include the following:

(A) A summary of the nonclinical laboratory

studies submitted in the application;

(B) A summary of the clinical investigations involv-

ing human subjects submitted in the application includ-

ing a discussion of subject selection and exclusion

criteria, study population, study period, safety and effec-

tiveness data, adverse reactions and complications,

patient discontinuation, patient complaints, device fail-

ures and replacements, results of statistical analyses of

the clinical investigations, contraindications and precau-

tions for use of the device, and other information from

the clinical investigations as appropriate (any investiga-

tion conducted under an IDE shall be identified as such).

(vi) Conclusions drawn from the studies. A discus-

sion demonstrating that the data and information in the

application constitute valid scientific evidence within the

meaning of § 860.7 and provide reasonable assurance that

the device is safe and effective for its intended use. A

App. 58

concluding discussion shall present benefit and risk con-

siderations related to the device including a discussion of

any adverse effects of the device on health and any

proposed additional studies or surveillance the applicant

intends to conduct following approval of the PMA.

(4) A complete description of:

(i) The device, including pictorial representations;

(ii) Each of the functional components or ingre-

dients of the device if the device consists of more than

one physical component or ingredient;

(iii) The properties of the device relevant to the

diagnosis, treatment, prevention, cure, or mitigation of a.

disease or condition;

(iv) The principles of operation of the device; and

(v) The methods used in, and the facilities and con-

trols used for, the manufactyre, processing, packing, stor-

age, and, where appropriate, installation of the device, in

sufficient detail so that a person generally familiar with

current good manufacturing practice can make a knowl-

edgeable judgment about the quality control used in the

manufacture of the device.

(5) Reference to any performance standard under

section 514 of the act or the Radiation Control for Health

and Safety Act of 1968 (42 U.S.C. 263b et seq.) in effect or

proposed at the time of the submission and to any volun-

tary standard that is relevant to any aspect of the safety

or effectiveness of the device and that is known to or that

should reasonably be known to the applicant. The appli-

cant shall —

App. 59

(i) Provide adequate information to demonstrate

how the device meets, or justify any deviation from, any

performance standard established under section 514 of

the act or under the Radiation Control for Health and

Safety Act, and

(ii) Explain any deviation from a voluntary stan-

dard.

(6) The following technical sections which shall

contain data and information in sufficient detail to permit

FDA to determine whether to approve or deny approval

of the application:

(i) A section containing results of the nonclinical

laboratory studies with the device including micro-

biological, toxicological, immunological, biocompatibility,

stress, wear, shelf life, and other laboratory or animal

tests as appropriate. Information on nonclinical labora-

tory studies shall include a statement that each such

study was conducted in compliance with Part 58, or, if the

study was not conducted in compliance with such regula-

tions, a brief statement of the reason for the noncom-

pliance.

(ii) A section containing results of the clinical inves-

tigations involving human subjects with the device

including clinical protocols, number of investigators and

subjects per investigator, subject selection and exclusion

criteria, study population, study period, safety and effec-

tiveness data, adverse reactions and complications,

patient discontinuation, patient complaints, device fail-

ures and replacements, tabulations of data from all indi-

vidual subject report forms and copies of such forms for

each subject who died during a clinical investigation or

App. 60

who did not complete the investigation, results of statisti-

cal analyses of the clinical investigations, device failures

and replacements, contraindications and precautions for

use of the device, and any other appropriate information

from the clinical investigations. Any investigation con-

ducted under an IDE shall be identified as such. Informa-

tion on clinical investigations involving human subjects

shall include the following:

(A) A statement with respect to each study that it

either was conducted in compliance with the institutional

review board regulations in Part 56, or was not subject to

the regulations under § 56.104 or § 56.105, and that it was

conducted in compliance with the informed consent regu-

lations in Part 50; or if the study was not conducted in

compliance with those regulations, a brief statement of

the reason for the noncompliance.

(B) A statement that each study was conducted in

compliance with Part 812 or Part 813 concerning sponsors

of clinical investigations and clinical investigators, or if

the study was not conducted in compliance with those

regulations, a brief statement of the reason for the non-

compliance.

(7) For a PMA supported solely by data from one

investigation, a justification showing that data and other

information from a single investigator are sufficient to

demonstrate the safety and effectiveness of the device

and to ensure reproducibility of test results.

(8)(i) A bibliography of all published reports not

submitted under paragraph (b)(6) of this section, whether

App. 61

adverse or supportive, known to or that should reason-

ably be known to the applicant and that concern the

safety or effectiveness of the device.

(ii) An identification, discussion, and analysis of

any other data, information, or report relevant to an

evaluation of the safety and effectiveness of the device

known to or that should reasonably be known to the

applicant from any source, foreign or domestic, including

information derived from investigations other than those

proposed in the application and from commercial market-

ing experience.

(iii) Copies of such published reports or

unpublished information in the possession of or reason-

ably obtainable by the applicant if an FDA. advisory

committee or FDA requests.

(9) One or more samples of the device and its com-

ponents, if requested by FDA. If it is impractical to sub-

mit a requested sample of the device, the applicant shall

name the location at which FDA may examine and test

one or more devices.

(10) Copies of all proposed labeling for the device.

Such labeling may include, e.g., instructions for installa-

tion and any information, literature, or advertising that

constitutes labeling under section 201(m) of the act.

(11) An environmental assessment under

§ 25.22(a)(18) prepared in the applicable format in § 25.31,

unless the action qualifies for exclusion under § 25.24(e)

(4) or (5). If the applicant believes that the action qualifies

for exclusion, the PMA shall under § 25.23(c) provide

information that establishes to FDA’s satisfaction that the

App. 62

action requested is included within the excluded category

and meets the criteria for the applicable exclusion.

(12) Such other information as FDA may request. If

necessary, FDA will obtain the concurrence of the appro-

priate FDA advisory committee before requesting addi-

tional information.

referred to by an applicant may be incorporated into a

PMA by reference. Information in a master file or other

information submitted to FDA by a person other than the

applicant will not be considered part of a PMA unless

such reference is authorized in writing by the person who

submitted the information or the master file. If a master

file is not referenced within 5 years after the date that it is

submitted to FDA, FDA will return the master file to the

person who submitted it.

(d) If the applicant believes that certain information

required under paragraph (b) of this section to be in a

PMA is not applicable to the device that is the subject of

the PMA, and omits any such information from its PMA,

the applicant shall submit a statement that identifies the

omitted information and justifies the omission. The state-

ment shall be submitted as a separate section in the PMA

and identified in the table of contents. If the justification

for the omission is not accepted by the agency, FDA will

so notify the applicant.

(e) The applicant shall periodically update its pend-

ing application with new safety and effectiveness infor-

mation learned about the device from ongoing or

completed studies that may reasonably affect an evalua-

tion of the safety or effectiveness of the device or that

App. 63

may reasonably affect the statement of contraindications,

warnings, precautions, and adverse reactions in the draft

labeling. The update report shall be consistent with the

data reporting provisions of the protocol. The applicant

shall submit three copies of any update report and shall

include in the report the number assigned by FDA to the

PMA. These updates are considered to be amendments to

the PMA. The time frame for review of a PMA will not be

extended due to the submission of an update report

unless the update is a major amendment under

§ 814.37(c)(1). The applicant shall submit these reports -

(1) 3 months after the filing date,

(2) Following receipt of an approvable letter, and

(3) At any other time as requested by FDA.

(f) Ifacolor additive subject to section 721 of the act

is used in or on the device and has not previously been

listed for such use, then, in lieu of submitting a color

additive petition under Part 71, at the option of the

applicant, the information required to be submitted

under Part 71 may be submitted as part of the PMA.

When submitted as part of the PMA, the information

shall be submitted in three copies each bound in one or

more numbered volumes of reasonable size. A PMA for a

device that contains a color additive that is subject to

section 721 of the act will not be approved until the color

additive is listed for use in or on the device.

(g) FDA has issued a PMA guideline to assist the

applicant in the arrangement and content of a PMA. This

guideline is available from the Center for Devices and

Radiological Health, Office of Standards and Regulations

App. 64

(HFZ-80), Food and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857.

(h) A PMA, PMA amendment, PMA supplement, or

correspondence with respect to a PMA shall be sent to the

PMA Document Mail Center (HFZ-401), Center for

Devices and Radiological Health, Food and Drug Admin-

istration, 1390 Piccard Dr., Rockville, MD 20850.

21 CFR § 860.7 Determination of safety and effectiveness.

(a) The classification panels, in reviewing evidence

concerning the safety and effectiveness of a device and in

preparing advice to the Commissioner, and the Commis-

sioner, in making determinations concerning the safety

and effectiveness of a device, will apply the rules in this

section.

(b) In determining the safety and effectiveness of a

device for purposes of classification, establishment of

performance standards for class II devices, and pre-

market approval of class III devices, the Commissioner

and the classification panels will consider the following,

among other relevant factors:

(1) The persons for whose use the device is repre-

sented or intended; |

(2) The conditions of use for the device, including

conditions of use prescribed, recommended, or suggested

in the labeling or advertising of the device, and other

intended conditions of use;

(3) The probable benefit to health from the use of

the device weighed against any probable injury or illness

from such use; and

App. 65

(4) The reliability of the device.

(c)(1) Although the manufacturer may submit any

form of evidence to the Food and Drug Administration in

an attempt to substantiate the safety and effectiveness of

a device, the agency relies upon only valid scientific

evidence to determine whether there is reasonable assur-

ance that the device is safe and effective. After consider-

ing the nature of the device and the rules in this section,

the Commissioner will determine whether the evidence

submitted or otherwise available to the Commissioner is

valid scientific evidence for the purpose of determining

the safety or effectiveness of a particular device and

whether the available evidence, when taken as a whole, is

adequate to support a determination that there is reason-

able assurance that the device is safe and effective for its

conditions of use.

(2) Valid scientific evidence is evidence from well-

controlled investigations, partially controlled studies,

studies and objective trials without matched controls,

well-documented case histories conducted by qualified

experts, and reports of significant human experience with

a marketed device, from which it can fairly and responsi-

bly be concluded by qualified experts that there is reason-

able assurance of the safety and effectiveness of a device

under its conditions of use. The evidence required may

vary according to the characteristics of the device, its

conditions of use, the existence and adequacy of warn-

ings and other restrictions, and the extent of experience

with its use. Isolated case reports, random experience,

reports lacking sufficient details to permit scientific eval-

uation, and unsubstantiated opinions are not regarded as

valid scientific evidence to show safety or effectiveness.

App. 66

Such information may be considered, however, in identi-

fying a device the safety and effectiveness of which is

questionable.

(d)(1) There is reasonable assurance that a device is

safe when it can be determined, based upon valid scien-

tific evidence, that the probable benefits to health from

use of the device for its intended uses and conditions of

use, when accompanied by adequate directions and

warnings against unsafe use, outweigh any probable

risks. The valid scientific evidence used to determine the

safety of a device shall adequately demonstrate the

absence of unreasonable risk of illness or injury associ-

ated with the use of the device for its intended uses and

conditions of use.

(2) Among the types of evidence that may be

required, when appropriate, to determine that there is

reasonable assurance that a device is safe are investiga-

tions using laboratory animals, investigations involving

human subjects, and nonclinical investigations including

in vitro studies.

(e)(1) There is reasonable assurance that a device is

effective when it can be determined, based upon valid

scientific evidence, that in a significant portion of the

target population, the use of the device for its intended

uses and conditions of use, when accompanied by ade-

quate directions for use and warnings against unsafe use,

will provide clinically significant results.

(2) The valid scientific evidence used to determine

the effectiveness of a device shall consist principally of

well-controlled investigations, as defined in paragraph (f)

of this section, unless the Commissioner authorizes

App. 67

reliance upon other valid scientific evidence which the

Commissioner has determined is sufficient evidence from

which to determine the effectiveness of a device, even in

the absence of well-controlled investigations. The Com-

missioner may make such a determination where the

requirement of well-controlled investigations in para-

graph (f) of this section is not reasonably applicable to

the device.

(f) The following principles have been developed

over a period of years and are recognized by the scientific

community as the essentials of a well-controlled clinical

investigation. They provide the basis for the Commis-

sioner’s determination whether there is reasonable assur-

ance that a device is effective based upon well-controlled

investigations and are also useful in assessing the weight

to be given to other valid scientific evidence permitted

under this section.

(1) The plan or protocol for the study and the report

of the results of a well-controlled investigation shall

include the following:

(i) A clear statement of the objectives of the study;

(ii) A method of selection of the subjects that:

(a) Provides adequate assurance that the subjects

are suitable for the purposes of the study, provides diag-

nostic criteria of the condition to be treated or diagnosed,

provides confirmatory laboratory tests where appropriate

and, in the case of a device to prevent a disease or

condition, provides evidence of susceptibility and expo-

sure to the condition against which prophylaxis is

desired;

App. 68

(b) Assigns the subjects to test groups, if used, in

such a way as to minimize any possible bias;

any control groups of pertinent variables such as sex,

severity or duration of the disease, and use of therapy

other than the test device;

(iii) An explanation of the methods of observation

and recording of results utilized, including the variables

measured, quantitation, assessment of any subject's

response, and steps taken to minimize any possible bias

of subjects and observers;

(iv) A comparison of the results of treatment or

diagnosis with a control in such a fashion as to permit

quantitative evaluation. The precise nature of the control

must be specified and an explanation provided of the

methods employed to minimize any possible bias of the

observers and analysts of the data. Level and methods of

“blinding,” if appropriate and used, are to be docu-

mented. Generally, four types of comparisons are recog-

nized:

(a) No treatments. Where objective measurements

of effectiveness are available and placebo effect is neglig-

ible, comparison of the objective results in comparable

groups of treated and untreated patients;

(b) Placebo control. Where there may be a placebo

effect with the use of a device, comparison of the results

of use of the device with an ineffective device used under

conditions designed to resemble the conditions of use

under investigation as far as possible;

App. 69

imen of therapy may be used for comparison, e.g., the

condition being treated is such that the use of a placebo

or the withholding of treatment would be inappropriate

or contrary to the interest of the patient;

(d) Historical control. In certain circumstances, such

as those involving diseases with high and predictable

mortality or signs and symptoms of predictable duration

or severity, or in the case of prophylaxis where morbidity

is predictable, the results of use of the device may be

compared quantitatively with prior experience histori-

cally derived from the adequately documented natural

history of the disease or condition in comparable patients

or populations who received no treatment or who fol-

lowed an established effective regimen (therapeutic, diag-

nostic, prophylactic).

(v) A summary of the methods of analysis and an

evaluation of the data derived from the study, including

any appropriate statistical methods utilized.

(2) To insure the reliability of the results of an

investigation, a well-controlled investigation shall

involve the use of a test device that is standardized in its

composition or design and performance.

(g)(1) It is the responsibility of each manufacturer

and importer of a device to assure that adequate, valid

scientific evidence exists, and to furnish such evidence to

the Food and Drug Administration to provide reasonable

assurance that the device is safe and effective for its

intended uses and conditions of use. The failure of a

manufacturer or importer of a device to present to the

Food and Drug Administration adequate, valid scientific

App. 70

evidence showing that there is reasonable assurance of

the safety and effectiveness of the device, if regulated by

general controls alone, or by general controls and perfor-

mance standards, may support a determination that the

device be classified into class III.

(2) The Commissioner may require that a manufac-

turer, importer, or distributor make reports or provide

other information bearing on the classification of a device

and indicating whether there is reasonable assurance of

the safety and effectiveness of the device or whether it is

adulterated or misbranded under the act.

(3) A requirement for a report or other information

under this paragraph will comply with section 519 of the

act. Accordingly, the requirement will state the reason or

purpose for such request; will describe the required

report or information as clearly as possible; will not be

imposed on a manufacturer, importer, or distributor of a

classified device that has been exempted from such a

requirement in accordance with § 860.95; will prescribe

the time for compliance with the requirement; and will

prescribe the form and manner in which the report or

information is to be provided.

(4) Required information that has been submitted

previously to the Center for Devices and Radiological

Health need not be resubmitted, but may be incorporated

by reference.

21 CFR § 808.1 Scope

(a) This part prescribes procedures for the submis-

sion, review, and approval of applications for exemption

App. 71

from Federal preemption of State and local requirements

applicable to medical devices under section 521 of the act.

(b) Section 521(a) of the act contains special provi-

sions governing the regulation of devices by States and

localities. That section prescribes a general rule that after

May 28, 1976, no State or political subdivision of a State

may establish or continue in effect any requirement with

respect to a medical device intended for human use hav-

ing the force and effect of law (whether established by

statute, ordinance, regulation, or court decision), which is

different from, or in addition to, any requirement applica-

ble to such device under any provision of the act and

which relates to the safety or effectiveness of the device

or to any other matter included in a requirement applica-

ble to the device under the act.

whereby the Commissioner of Food and Drugs may, upon

application by a State or political subdivision, allow

imposition of a requirement which is different from, or in

addition to, any requirement applicable under the act to

the device (and which is thereby preempted) by pro-

mulgating a regulation in accordance with this part

exempting the State or local requirement from preemp-

tion. The granting of an exemption does not affect the

applicability to the device of any requirements under the

act. The Commissioner may promulgate an exemption

regulation for the preempted requirement if he makes

either of the following findings:

(1) That the requirement is more stringent than a

requirement under the act applicable to the device; or

App. 72

(2) That the requirement is required by compelling

local conditions and compliance with the requirement

would not cause the device to be in violation of any

applicable requirement under the act.

(d) State or local requirements are preempted only

when the Food and Drug Administration has established

specific counterpart regulations or there are other specific

requirements applicable to a particular device under the

act, thereby making any existing divergent State or local

requirements applicable to the device different from, or in

addition to, the specific Food and Drug Administration

requirements. There are other State or local requirements

that affect devices that are not preempted by section

521(a) of the act because they are not “requirements

applicable to a device” within the meaning of section

521(a) of the act. The following are examples of State or

local requirements that are not regarded as preempted by

section 521 of the act:

(1) Section 521(a) does not preempt State or local

requirements of general applicability where the purpose

of the requirement relates either to other products in

addition to devices (e.g., requirements such as general

electrical codes, and the Uniform Commercial Code (war-

ranty of fitness)), or to unfair trade practices in which the

requirements are not limited to devices.

(2) Section 521(a) does not preempt State or local

requirements that are equal to, or substantially identical

to, requirements imposed by or under the act.

(3) Section 521(a) does not preempt State or local

permits, licensing, registration, certification, or other

requirements relating to the approval or sanction of the

App. 73

practice of medicine, dentistry, optometry, pharmacy,

nursing, podiatry, or any other of the healing arts or

allied medical sciences or related professions or occupa-

tions that administer, dispense, or sell devices. However,

regulations issued under section 520(e) or (g) of the act

may impose restrictions on the sale, distribution, or use

of a device beyond those prescribed in State or local

requirements. If there is a conflict between such restric-

tions and State or local requirements, the Federal regula-

tions shall prevail.

(4) Section 521(a) does not preempt specifications in

contracts entered into by States or localities for procure-

ment of devices.

(5) Section 521(a) does not preempt criteria for pay-

ment of State or local obligations under Medicaid and

similar Federal, State or local health-care programs.

(6)(i) Section 521(a) does not preempt State or local

requirements respecting general enforcement, e.g.,

requirements that State inspection be permitted of factory

records concerning all devices, registration, and licensing

requirements for manufacturers and others, and prohibi-

tion of manufacture of devices in unlicensed establish-

ments. However, Federal regulations issued under

sections 519 and 520(f) of the act may impose require-

ments for records and reports and good manufacturing

practices beyond those prescribed in State or local

requirements. If there is a conflict between such regula-

tions and State or local requirements, the Federal regula-

tions shall prevail.

(ii) Generally, section 521(a) does not preempt a

State or local requirement prohibiting the manufacture of

App. 74

adulterated or misbranded devices. Where, however,

such a prohibition has the effect of establishing a substan-

tive requirement for a specific device, e.g., a specific

labeling requirement, then the prohibition will be pre-

empted if the requirement is different from, or in addition

to, a Federal requirement established under the act. In

determining whether such a requirement is preempted,

the determinative factor is how the requirement is inter-

preted and enfcrced by the State or local government and

not the literal language of the statute, which may be

identical to a provision in the act.

(7) Section 521(a) does not preempt State or local

provisions respecting delegations of authority and related

administrative matters relating to devices.

(8) Section 521(a) does not preempt a State or local

requirement whose sole purpose is raising revenue or

charging fees for services, registration, or regulatory pro-

grams.

(9) Section 521(a) does not preempt State or local

requirements of the types that have been developed

under the Atomic Energy act of 1954 (42 U.S.C. 2011

note), as amended, the Radiation Control for Health and

Safety Act of 1968 (Pub. L. 90-602 (42 U.S.C. 263b et seq.))

and other Federal statutes, until such time as the Food

and Drug Administration issues specific requirements

under the Federal Food, Drug, and Cosmetic Act applica-

ble to these types of devices.

(e) It is the responsibility of the Food and Drug

Administration, subject to review by Federal courts, to

determine whether a State or local requirement is equal

to, or substantially identical to, requirements imposed by

App. 75

or under the act, or is different from, or in addition to,

such requirements, in accordance with the procedures

provided by this part. However, it is the responsibility of

States and political subdivisions to determine initially

whether to seek exemptions from preemption. Any State

or political subdivision whose requirements relating to

devices are preempted by section 521(a) may petition the

Commissioner of Food and Drugs for exemption from

preemption, in accordance with the procedures provided

by this part.

(f) The Federal requirement with respect to a device

applies whether or not a corresponding State or local

requirement is preempted or exempted from preemption.

As a result, if a State or local requirement that the Food

and Drug Administration has exempted from preemption

is not as broad in its application as the Federal require-

ment, the Federal requirement applies to all circum-

stances not covered by the State or local requirement.

21 CFR § 886.5928 Soft (hydrophilic) contact lens solution.

(a) Identification. A soft (hydrophilic) contact lens

solution is a device intended to clean, disinfect, wet, or

store a soft (hydrophilic) contact lens (s 886.5925).

(b) Classification. Class III.

required. As of May 28, 1976, an approval under section

515 of the act is required before this device may be

commercially distributed. See § 886.3.

App. 76

21 CFR Section 808:

“(a) This part prescribes procedures for the

submission, review, and approval of applica-

tions for exemption from Federal preemption of

State and local requirements applicable to medi-

cal devices under section 521 of the act.

(b) Section 521(a) of the act contains spe-

cial provisions governing the regulation of

devices by States and localities. That section

prescribes a general rule that after May 28, 1976,

no State or political subdivision of a State may

establish or continue in effect any requirement

with respect to a medical device intended for

human use having the force and effect of law

(whether established by statute, ordinance, reg-

ulation, or court decision), which is different

from, or in addition to, any requirement applica-

ble to such device under any provision of the act

and which relates to the safety or effectiveness

of the device or to any other matter included in

a requirement applicable to the device under the

act.

* * *

(d) State or local requirements are pre-

empted only when the Food and Drug Adminis-

tration has established specific counterpart

regulations or there are other specific require-

ments applicable to a particular device under

the act, thereby making any existing divergent

State or local requirements applicable to the

device different from, or in addition to, the spec-

ific Food and Drug Administration require-

ments. There are other State or local

requirements that affect devices that are not pre-

empted by section 521(a) of the act because they

App. 77

are not ‘requirements applicable to a device’

within the meaning of section 521(a) of the act.

The following are examples of State or local

requirements that are not regarded as pre-

empted by section 521 of the act:

‘(1) Section 521(a) does not preempt State or

local requirements of general applicability

where the purpose of the requirement relates

either to other products in addition to devices

(e.g., requirements such as general electrical

codes, and the Uniform Commercial Code

(warranty of fitness), or to unfair trade prac-

tices in which the requirements are not limited

to devices.

(2) Section 521(a) does not preempt State or

local requirements that are equal to, or sub-

stantially identical to, requirements imposed

by or under the act.

(3) Section 521(a) does not preempt State or

local permits, licensing, registration, certifica-’

tion, or other requirements relating to the

approval or sanction of the practice of medi-

cine, dentistry, optometry, pharmacy, nursing,

podiatry, or any other of the healing arts or

allied medical sciences or related professions

or occupations that administer, dispense, or

sell devices. However, regulations issued

under section 520(e) or (g) of the act may

impose restrictions on the sale, distribution,

or use of a device beyond those prescribed in

State or local requirements. If there is a con-

flict between such restrictions and State or

local requirements, the Federal regulations

shall prevail.

App. 78

(4) Section 521(a) does not preempt speci-

fications in contracts entered into by States or

localities for procurement of devices.

(5) Section 521(a) does not preempt criteria

for payment of State or local obligations

under medicaid and similar Federal, State or

local health-care programs.

(6)(i) Section 521(a) does not preempt State

or local requirements respecting general

enforcement, e.g., requirements that State

inspection be permitted of factory records

concerning all devices, registration, and

licensing requirements for manufacturers and

others, and prohibition of manufacture of

devices in unlicensed establishments. How-

ever, Federal regulations issued under sec-

tions 519 and 520(f) of the act may impose

requirements for records and reports and

good manufacturing practices beyond those

prescribed in State or local requirements. If

there is a conflict between such regulations

and State or local requirements, the Federal

regulations shall prevail.

(ii) Generally, section 521(a) does not pre-

empt a State or local requirement prohibiting

the manufacture of adulterated or misbranded

devices. Where, however, such a prohibition

has the effect of establishing a substantive

requirement for a specific device, e.g., a speci-

fic labeling requirement, then the prohibition

will be preempted if the requirement is differ-

ent from or in addition to, a Federal require-

ment established under the act. In

determining whether such a requirement is

preempted, the determinative factor is how

the requirement is interpreted and enforced

App. 79

by the State or local government and not the

literal language of the statute, which may be

identical to a provision in the act.

(7) Section 521(a) does not preempt State or

local provisions respecting delegations of

authority and related administrative matters

relating to devices.

(8) Section 521(a) does not preempt a State

or local requirement whose sole purpose is

raising revenue or charging fees for services,

registration, or regulatory programs.

(9) Section 521(a) does not preempt State or

local requirements of the types that have been

developed under the Atomic Energy act of

1954 (42 U.S.C. 2011 note), as amended, the

Radiation Control for Health and Safety Act of

1968 (Pub. L. 90-602 (42 U.S.C. 263b et seq.)

and other Federal statutes, until such time as

the Food and Drug Administration issues

specific requirements under the Federal Food,

Drug, and Cosmetic Act applicable to these

types of devices.’ ”

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.