Ophthalmic Devices: Reclassification of Rigid Gas Permeable Contact Lens Solution; Soft (Hydrophilic) Contact Lens Solution; and Contact Lens Heat Disinfecting Unit

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 886

[Docket No. 95N-0400]

Ophthalmic Devices: Reclassification of Rigid Gas Permeable

Contact Lens Solution; Soft (Hydrophilic) Contact Lens Solution; and

Contact Lens Heat Disinfecting Unit

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule

reclassifying from class III (premarket approval) to class II (special

controls) rigid gas permeable contact lens solution, soft (hydrophilic)

contact lens solution, and the contact lens heat disinfection unit.

Collectively, these devices are referred to as transitional contact

lens care products, which include saline solutions; in-eye lubricating/

rewetting drops; disinfecting and conditioning products; contact lens

cleaners; and heat disinfecting units. This reclassification is in

accordance with provisions in the Federal Food, Drug, and Cosmetic Act

(the act), as amended by the Medical Device Amendments of 1976 (the

1976 amendments) and the Safe Medical Devices Act of 1990 (the SMDA).

Elsewhere in this issue of the Federal Register, FDA is announcing the

availability of a guidance describing the evidence that may demonstrate

the substantial equivalence of new contact lens care products to

legally marketed predicate lens care products.

EFFECTIVE DATE: July 7, 1997.

FOR FURTHER INFORMATION CONTACT: James F. Saviola, Center for Devices

and Radiological Health (HFZ-460), Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850, 301-594-1744.

SUPPLEMENTARY INFORMATION:

I. Background

The act (21 U.S.C. 321 et. seq.), as amended by the 1976 amendments

(Pub. L. 94-295) and the SMDA (Pub. L. 101-629), established a

comprehensive system for the regulation of medical devices intended for

human use. Section 513 of the act (21 U.S.C. 360c) establishes three

classes of devices, depending on the regulatory controls needed to

provide reasonable assurance of their safety and effectiveness: Class

I, general controls; class II, special controls; and class III,

premarket approval.

The 1976 amendments broadened the definition of ``device'' in

section 201(h) of the act (21 U.S.C. 321(h)) to include certain

articles that were once regulated as drugs. Under the 1976 amendments,

Congress classified into class III all transitional devices (i.e.,

those devices previously regulated as new drugs). The legislative

history of the SMDA reflects congressional concern that many

transitional devices were being overregulated in class III (H. Rept.

808, 101st Cong., 2d sess. 26-27 (1990); S. Rept. 513, 101st Cong., 2d

sess. 26-27 (1990)). Congress amended section 520(l) of the act (21

U.S.C. 360j(l)) to direct FDA to collect certain safety and

effectiveness information from the manufacturers of transitional

devices still remaining in class III to determine whether the devices

should be reclassified into class II (special controls) or class I

(general controls). Accordingly, in the Federal Register of November

14, 1991 (56 FR 57960), FDA issued an order under section 520(l)(5)(A)

of the act, requiring manufacturers of transitional devices, including

rigid gas permeable contact lens solution (Sec. 886.5918 (21 CFR

886.5918)); soft (hydrophilic) contact lens solution (Sec. 886.5928 (21

CFR 886.5928)); and the contact lens heat disinfection unit

(Sec. 886.5933 (21 CFR 886.5933)), to submit to FDA a summary of, and a

citation to, any information known or otherwise available to them

respecting the devices, including adverse safety or effectiveness

information which had not been submitted under section 519 of the act

(21 U.S.C. 360i). Manufacturers were to submit the summaries and

citations to FDA by January 13, 1992. However, because of

misunderstandings and uncertainties regarding the information required

by the order, and whether the order applied to certain manufacturers'

devices, many transitional class III device manufacturers failed to

comply with the reporting requirement by January 13, 1992.

Consequently, in the Federal Register of March 10, 1992 (57 FR 8462),

FDA extended the reporting period to March 31, 1992.

Section 520(l)(5)(B) of the act, provides that, after the issuance

of an order requiring manufacturers to submit a summary of, and

citation to, any information known or otherwise available respecting

the devices, but before December 1, 1992, FDA was to publish

regulations either leaving transitional class III devices in class III

or reclassifying them into class I or II. Subsequently, as permitted by

section 520(l)(5)(C) of the act, in the Federal

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Register of November 30, 1992 (57 FR 56586), the agency published a

notice extending the period for issuing such regulations until December

1, 1993. Due to limited resources, FDA was unable to publish the

regulations before the December 1, 1993, deadline.

In the Federal Register of April 1, 1996 (61 FR 14277), FDA

published a proposed rule to reclassify from class III (premarket

approval) to class II (special controls) rigid gas permeable contact

lens solution, soft (hydrophilic) contact lens solution, and the

contact lens heat disinfecting unit. The proposed rule contained

reasons for the proposed reclassification, identified the risks to

health presented by the device, and included a summary of the data upon

which the proposed reclassification was based. Written comments were

requested by June 17, 1996.

II. Summary and Analysis of Comments and FDA's Responses

Only one person from the public commented on the proposal. This

comment stated that: (1) The proposed rule did not provide a rational

basis for reclassification because it did not summarize, or provide a

bibliography of, supporting safety and effectiveness information so

that interested persons could challenge the proposal; (2) FDA was

basing its reclassification on protected information in approved

premarket approval applications (PMA's) and on information submitted in

response to the order issued under section 520(l)(5)(A) of the act; and

(3) the special control document only addresses safety issues and does

not encompass device effectiveness.

FDA disagrees that the proposed rule did not provide a rational

basis for reclassification of these devices. Section 520(l)(5)(B)

states: ``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 513(a).'' In accordance

with those criteria, FDA has determined that special controls, in the

form of the 510(k) guidance document would provide reasonable assurance

of the safety and effectiveness of these devices. FDA made this

determination based on its identification of the risks to health

presented by these devices and on its review of preclinical and

clinical data and adverse experience reports. FDA did not use

information made available under section 520(h)(1) or (h)(2) of the act

to ``establish the safety or effectiveness of another device'', as

alleged by the comment.

The SMDA mandates that FDA review the classification of

transitional devices and reclassify them into class I or class II

unless FDA can justify requiring them to remain in class III. FDA has

determined that premarket approval is not necessary for these devices

because a special control entitled, ``Guidance for Industry; Premarket

Notification (510(k)) Guidance Document for Contact Lens Care

Products,'' is sufficient to provide reasonable assurance of the safety

and effectiveness of the devices. Consequently, FDA cannot justify

requiring these devices to remain in class III.

FDA believes that it was Congress' intent that, whenever possible,

FDA use the historical information and expertise it has obtained in

reviewing scientific data to designate special controls that can be

used as a basis for reclassifying devices. FDA has had over 25 years of

experience in reviewing and evaluating preclinical and clinical data

contained in more than 100 PMA's; hundreds of PMA annual reports that

include identification of adverse reactions reported for the device;

the medical device reporting (MDR) data base within FDA; information

submitted under section 520(l)(5)(A) of the act; and volumes of

scientific literature for contact lens care products. FDA did not

publish a bibliography of literature articles supporting safety and

effectiveness information because of the voluminous number of

literature articles published for all of the devices included in this

reclassification. FDA is not using data from PMA's to support

reclassification of these devices and will not disclose protected

information in approved PMA's.

FDA disagrees that the guidance document does not address

effectiveness issues. Some examples of recommended testing to address

effectiveness included in the document are cleaning effectiveness,

compatibility testing, and clinical testing to confirm results of

preclinical testing.

The same comment suggested that the agency clarify the

classification status of contact lens cases.

At the January 26, 1995, meeting of the Ophthalmic Devices Panel,

members unanimously recommended that contact lens cases be classified

in class II. In the near future, FDA intends to publish a proposal in

the Federal Register classifying contact lens cases in class II and

including them under Sec. 886.5928.

In accordance with sections 520(l)(5)(B) and 513(a) of the act, FDA

is reclassifying rigid gas permeable contact lens solution

(Sec. 886.5918); soft (hydrophilic) contact lens solution

(Sec. 886.5928); and the contact lens heat disinfection unit

(Sec. 886.5933) from class III (premarket approval) to class II

(special controls). FDA does not believe that these devices can be

classified into class I because general controls by themselves are

insufficient to provide reasonable assurance of the safety and

effectiveness of the devices. However, FDA does believe that these

devices can be classified into class II because sufficient information

exists to establish special controls to provide reasonable assurance of

their safety and effectiveness. The revised guidance document entitled,

``Guidance for Industry; Premarket Notification (510(k)) Guidance

Document for Contact Lens Care Products,'' the availability of which is

being announced elsewhere in this issue of the Federal Register, is the

special control that FDA believes is necessary to provide such

assurance.

III. Transitional Phase for Pending PMA's for Contact Lens Care

Products

Below, FDA discusses how it will deal with the pending original and

supplemental PMA's involving contact lens care products currently filed

with the agency. As of today's date, all pending PMA applications will

need to be examined to identify: (1) Those that are no longer subject

to PMA review and can be converted to 510(k)'s or withdrawn and

resubmitted to FDA by the sponsor to be evaluated through the 510(k)

process; and (2) those that can be withdrawn by the sponsor and are not

required to be resubmitted and evaluated as a 510(k) prior to

implementing the request. FDA will make all final decisions on

converted PMA's based on 510(k) regulatory requirements as elaborated

in the document entitled, ``Guidance for Industry; Premarket

Notification (510(k)) Guidance Document for Contact Lens Care

Products.''

To ensure expeditious conversions, sponsors should review their

pending PMA's and advise the agency as to what administrative action

the sponsor believes needs to be taken regarding their pending

applications affected by the reclassification. As of the effective date

of this final rule, FDA will suspend the review of each pending

original and supplemental PMA affected in whole or in part by this

reclassification until the respective sponsor amends its application,

setting forth the status of the device and the administrative action

requested.

To convert a pending original or supplemental PMA to a 510(k), the

sponsor should submit an amendment to the applicable PMA or

supplemental PMA requesting that it be converted in total to a 510(k).

The amendment should: (1) Request that the application be converted in

total to a 510(k), (2) include a claim of substantial

[[Page 30987]]

equivalence to a previously approved contact lens care product (a

product included in this reclassification), and (3) provide all 510(k)

content requirements not submitted in the pending PMA or supplemental

PMA, thus making the application as complete as possible when converted

to a 510(k). Because preclinical and clinical data formerly required in

a PMA may be necessary to support a substantial equivalence

determination, a sponsor may provide references to applicable

preclinical and clinical data contained in the sponsor's approved

PMA('s) rather than duplicating the same data in a 510(k). When

referencing data previously reviewed by the agency, the sponsor should

clearly identify the relevant PMA number(s) and section(s) of the PMA

or supplemental PMA. Pending original or supplemental PMA's converted

to 510(k)'s will retain their position in the review queue (if they are

complete), and the review process will continue without further delay.

To withdraw and resubmit a pending original or supplemental PMA,

the sponsor should first submit an amendment to the applicable PMA

requesting that it be withdrawn. The sponsor should then determine

whether the request should be resubmitted and evaluated through the

510(k) process or be implemented without the need for submission of a

510(k). All original PMA's should be resubmitted as 510(k)'s. However,

not all supplemental PMA requests require the submission of a 510(k).

For example, unlike PMA's, under the 510(k) regulations, sponsors are

not required to submit a 510(k) for an additional manufacturing site

for a cleared device. To determine whether a 510(k) is required, the

sponsor should consult the 510(k) procedures (21 CFR part 807) and the

``Guidance for Industry Premarket Notification (510(k)) Guidance

Document for Contact Lens Care Products.'' Any required 510(k)

submission should follow the content and format requirements for

510(k)'s. However, sponsors may provide references to preclinical and

clinical data in the pending PMA or in approved PMA's rather than

duplicating the data in a 510(k). When referencing data previously

reviewed by the agency, the sponsor should clearly identify the

relevant PMA number(s) and sections of the PMA or supplemental PMA. The

sponsor should include in the 510(k) a claim of substantial equivalence

to an applicable legally marketed contact lens care product (a product

included in this reclassification) and a summary of safety and

effectiveness information or a statement that the sponsor will make the

safety and effectiveness information available to interested persons

upon request.

To withdraw a pending supplemental PMA that contains a request that

can be implemented without the need for submission of a 510(k), the

sponsor should submit an amendment to the applicable supplemental PMA

requesting that it be withdrawn.

In addition, sponsors should determine if there is information in

the pending PMA that would not be needed when resubmitted as a 510(k)

application. In making this determination, FDA cautions sponsors to

review the regulations pertaining to releasability of information in

PMA's and 510(k) submissions since different disclosure rules apply to

PMA's and 510(k) submissions. For this reason, a manufacturer may

choose not to have a pending PMA converted to a 510(k) submission, but

instead choose to withdraw the pending application, purge it of

unnecessary information that the sponsor might not want released, and

resubmit the relevant data in a new 510(k) submission.

If a sponsor fails to submit an amendment as outlined above within

180 days of the effective date of reclassification, FDA will consider

the pending PMA or PMA supplement to be voluntarily withdrawn. In such

cases, the agency will notify the sponsor by letter of the withdrawal.

All amendments to pending PMA's shall include the PMA or PMA supplement

number and shall be addressed to the PMA Document Mail Center (HFZ-

401), Center for Devices and Radiological Health, Office of Device

Evaluation, 9200 Corporate Blvd., Rockville, MD 20850. Additional

questions regarding administrative procedures resulting from this

reclassification should be directed to the PMA Staff (Kathy Poneleit,

301-594-2186), or to the Division of Ophthalmic Devices, Vitreoretinal

and Extraocular Devices Branch (James F. Saviola, or Muriel Gelles,

301-594-1744.)

IV. Environmental Impact

The agency has determined under 21 CFR 25.24(a)(8) that this action

is of a type that does not individually or cumulatively have a

significant effect on the human environment. Therefore, neither an

environmental assessment nor an environmental impact statement is

required.

V. Analysis of Impacts

FDA has examined the impacts of the final rule under Executive

Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612).

Executive Order 12866 directs agencies to assess all costs and benefits

of available regulatory alternatives and, when regulation is necessary,

to select regulatory approaches that maximize net benefits (including

potential economic, environmental, public health and safety, and other

advantages; distributive impacts; and equity). The agency believes that

this final rule is consistent with the regulatory philosophy and

principles identified in the Executive Order. In addition, the final

rule is not a significant regulatory action as defined by the Executive

Order and so is not subject to review under the Executive Order.

The Regulatory Flexibility Act requires agencies to analyze

regulatory options that would minimize any significant impact of a rule

on small entities. Because this final rule would reduce the regulatory

burdens for all manufacturers of contact lens care products covered by

this rule, the Commissioner of Food and Drugs certifies that the final

rule will not have a significant economic impact on a substantial

number of small entities. Therefore, under the Regulatory Flexibility

Act, no further analysis is required.

Accordingly, FDA is amending the regulations in Secs. 886.5918,

886.5928, and 886.5933 as set forth below.

List of Subjects in 21 CFR Part 886

Medical devices, Ophthalmic goods and services.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under

authority delegated to the Commissioner of Food and Drugs, 21 CFR part

886 is amended as follows:

PART 886--OPHTHALMIC DEVICES

1. The authority citation for 21 CFR part 886 continues to read as

follows:

Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,

371).

2. Section 886.5918 is revised to read as follows:

Sec. 886.5918 Rigid gas permeable contact lens care products.

(a) Identification. A rigid gas permeable contact lens care product

is a device intended for use in the cleaning, conditioning, rinsing,

lubricating/rewetting, or storing of a rigid gas permeable contact

lens. This includes all solutions and tablets used together with rigid

gas permeable contact lenses.

(b) Classification. Class II (Special Controls) Guidance Document:

[[Page 30988]]

``Guidance for Industry Premarket Notification (510(k)) Guidance

Document for Contact Lens Care Products.''

3. Section 886.5928 is revised to read as follows:

Sec. 886.5928 Soft (hydrophilic) contact lens care products.

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

is a device intended for use in the cleaning, rinsing, disinfecting,

lubricating/rewetting, or storing of a soft (hydrophilic) contact lens.

This includes all solutions and tablets used together with soft

(hydrophilic) contact lenses and heat disinfecting units intended to

disinfect a soft (hydrophilic) contact lens by means of heat.

(b) Classification. Class II (Special Controls) Guidance Document:

``Guidance for Industry Premarket Notification (510(k)) Guidance

Document for Contact Lens Care Products.''

Sec. 886.5933 [Removed and Reserved]

4. Section 886.5933 Contact lens heat disinfection unit is removed

and reserved.

Dated: May 28, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center for Devices and

Radiological Health.

[FR Doc. 97-14751 Filed 6-5-97; 8:45 am]

BILLING CODE 4160-01-F