Medical Devices; Reclassification of the Daily Wear Soft and Daily Wear Nonhydrophilic Plastic Contact Lenses; Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 93D-0441]

Medical Devices; Reclassification of the Daily Wear Soft and

Daily Wear Nonhydrophilic Plastic Contact Lenses; Premarket

Notification (510(k)) Guidance Document for Daily Wear Contact Lenses;

Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is issuing an order

reclassifying daily wear soft and daily wear nonhydrophilic plastic

contact lenses from class III (premarket approval) into class II

(special controls). This reclassification is required by the Safe

Medical Devices Act of 1990 (the SMDA). This reclassification only

applies to daily wear soft and daily wear nonhydrophilic contact

lenses. Lenses intended for extended wear will remain in class III, as

will contact lens accessories. The SMDA also requires FDA to put into

place any regulatory safeguards that are necessary to provide

reasonable assurance of the safety and effectiveness of the

reclassified lenses. Thus, FDA is announcing the availability of a

guidance document entitled ``Premarket Notification (510(k)) Guidance

Document for Daily Wear Contact Lenses.'' The guidance sets forth the

evidence that should be submitted to FDA to demonstrate the substantial

equivalence of new daily wear soft and daily wear nonhydrophilic

plastic contact lenses to lenses already marketed. Elsewhere in this

issue of the Federal Register, FDA is publishing a final rule to codify

the reclassification of the daily wear contact lens from class III

(premarket approval) into class II (special controls).

DATES: The reclassification is effective March 4, 1994. Written

comments on the guidance document may be submitted at any time.

ADDRESSES: Submit all amendments to pending premarket approval

applications (PMA's), including the PMA or PMA supplement number, to

the Food and Drug Administration, Center for Devices and Radiological

Health, PMA Document Mail Center (HFZ-401), 1390 Piccard Dr.,

Rockville, MD 20850. Submit written requests for single copies of

``Premarket Notification (510(k)) Guidance Document for Daily Wear

Contact Lenses'' to the Division of Small Manufacturers Assistance

(HFZ-220), Food and Drug Administration, 5600 Fishers Lane, Rockville,

MD 20857, 301-443-6597 or 800-638-2041. Send two self-addressed

adhesive labels to assist that office in processing your requests.

Submit written comments on the guidance document to the Dockets

Management Branch (HFA-350), Food and Drug Administration, rm. 1-23,

12420 Parklawn Dr., Rockville, MD 20857. Requests and comments should

be identified with the docket number found in brackets in the heading

of this document. The guidance document and received comments are

available for public examination in the Dockets Management Branch

between 9 a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: David M. Whipple, Center for Devices

and Radiological Health (HFZ-460), Food and Drug Administration, 1390

Piccard Dr., Rockville, MD 20850, 301-594-2205.

SUPPLEMENTARY INFORMATION:

I. The Statutory Requirements

The SMDA (Pub. L. 101-629), which amended the medical device

provisions of the Federal Food, Drug, and Cosmetic Act (the act) (21

U.S.C. 321-394) contained specific provisions on transitional devices

(i.e., those devices regulated as drugs before the Medical Device

Amendments of 1976 (Pub. L. 94-295) became law) (see section 520(l) of

the act (21 U.S.C. 360j(l))). In 1976, Congress classified all

transitional products, including daily wear soft and daily wear

nonhydrophilic plastic contact lenses, into class III (premarket

approval). Essentially the SMDA, reflecting congressional concern that

many transitional devices were being over regulated in class III,

directed FDA to collect certain safety and effectiveness information

from the manufacturers of transitional devices and review the

classifications of those transitional devices that still remained in

class III to determine if the devices could be down classified to class

II (special controls) or class I (general controls).

Under section 520(l)(5)(B) of the act, FDA was to publish

regulations by December 1, 1992, either leaving the transitional class

III devices in class III or revising their classifications down to

class I or class II. However, as permitted by section 520(l)(5)(c) of

the act, the agency, in the Federal Register of November 30, 1992 (57

FR 56586), published a notice extending the period for issuing such

regulations until December 1, 1993.

With respect to the reclassification of daily wear soft and daily

wear nonhydrophilic plastic contact lenses, however, the SMDA makes

further provision. Section 4(b)(3)(A) of the SMDA provides that

notwithstanding the provisions for reclassification of other

transitional devices, FDA shall not retain daily wear soft or daily

wear nonhydrophilic plastic contact lenses in class III unless the

agency determines that the devices meet the statutory criteria for a

class III device. Moreover, if FDA has not determined that these

contact lenses must remain in class III and published its finding by

November 28, 1993, in the Federal Register, then under section

4(b)(3)(D) of the SMDA, FDA ``shall issue an order placing the lenses

in class II.''

Both the language and legislative history of the SMDA make it clear

that the reclassification of daily wear soft and daily wear

nonhydrophilic contact lenses shall occur as a matter of law unless FDA

published a finding that the devices should remain in class III. FDA

has not made such a finding: FDA believes that the safety and

effectiveness of daily wear soft and daily wear nonhydrophilic plastic

contact lenses can be ensured through specified ``special controls'' as

authorized by the SMDA. Therefore, the agency has not made and

published any finding that daily wear soft and daily wear

nonhydrophilic contact lenses must remain in class III.

II. Order

Therefore, as required by section 4(b)(3)(D) of the SMDA, FDA is

issuing this order to all manufacturers of daily wear soft and daily

wear nonhydrophilic contact lenses reclassifying their devices from

class III (premarket approval) into class II (special controls). The

devices being reclassified are contact lenses intended for daily wear

that meet the following descriptions:

Rigid Gas Permeable Contact Lens. A rigid gas permeable contact

lens is a device intended to be worn directly against the cornea of the

eye to correct vision conditions. The device is made of various

materials, such as cellulose acetate butyrate, polyacrylate-silicone,

or silicone elastomers, whose main polymer molecules generally do not

absorb or attract water.

Soft (Hydrophilic) Contact Lens. A soft (hydrophilic) contact lens

is a device intended to be worn directly against the cornea and

adjacent limbal and scleral areas of the eye to correct vision

conditions or to act as a therapeutic bandage. The device is made of

various polymer materials, the main polymer molecules of which absorb

or attract a certain volume (percentage) of water.

III. Guidance

In addition to issuing this order as required by the SMDA, FDA is

issuing a guidance document for premarket notifications for the

reclassified contact lenses entitled, ``Premarket Notification (510(k))

Guidance Document for Daily Wear Contact Lenses.'' This guidance sets

forth the special controls that FDA has determined are needed to ensure

the safety and effectiveness of daily wear plastic contact lenses. It

also provides comprehensive directions to enable a manufacturer of a

daily wear soft or daily wear nonhydrophilic plastic contact lens to

submit a 510(k) premarket notification demonstrating substantial

equivalence of the device to a legally marketed daily wear plastic

contact lens (predicate device). Information on the battery of

preclinical testing necessary to demonstrate substantial equivalence is

included in the guidance. If the results of preclinical testing

demonstrate the device to have new characteristics, clinical

performance data may be needed to establish substantial equivalence. If

clinical performance data are needed, the guidance document provides

suggested methodologies (e.g., size and scope of the study) to be

included in an investigational protocol.

The preclinical portion of the guidance document consists of

manufacturing and chemistry, toxicology and microbiology sections

outlining the type of testing that should be completed. Each section

includes a summary of the basic requirements and suggested methods for

meeting these requirements. Other elements of the guidance document

include: (1) General information on the regulations and requirements

for labeling contact lenses; (2) requirements that must be met prior to

modifying a marketed contact lens; (3) suggested methodologies for

meeting color additive requirements; (4) procedures for adding lens

finishing laboratories for manufacturing and marketing of class II

rigid gas permeable contact lenses; and (5) the procedure for

implementing changes in packaging materials.

In the event that clinical trials are necessary, FDA emphasizes

that manufacturers must conduct the trials in accordance with the

Investigational Device Exemption regulations in 21 CFR part 812. At

this time, FDA considers clinical studies of daily wear soft or daily

wear nonhydrophilic plastic contact lenses to be nonsignificant risk

investigations. FDA considers clinical studies of extended wear contact

lenses to be significant risk investigations. Thus, for daily wear soft

or daily wear nonhydrophilic plastic contact lenses, an institutional

review board (IRB) approval is always necessary before initiating a

clinical study, and an investigational plan and informed consent

document must be presented to an IRB for review and approval. For

extended wear contact lenses, the manufacturer must obtain both IRB and

FDA approvals in accordance with 21 CFR part 812 before clinical

testing can be initiated.

This guidance document will be discussed at the next meeting of

the Ophthalmic Devices Panel of the Medical Devices Advisory Committee.

The date, time, and place of this meeting will be announced in a future

issue of the Federal Register.

IV. Transition Phase for Pending PMA's for Daily Wear Contact

Lenses

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

supplemental PMA's involving daily wear soft or daily wear

nonhydrophilic plastic contact lenses 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 applicant to be evaluated through the 510(k) process; and

(2) those which can be withdrawn by the applicant and are 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 ``Premarket

Notification (510(k)) Guidance Document for Daily Wear Contact

Lenses.''

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 automatic reclassification. FDA is

suspending the review of each pending original and supplemental PMA

affected in whole or in part by this reclassification order until the

respective sponsor amends its application setting forth the status of

the devices and the administrative actions requested to be taken

regarding its application.

These administrative actions can include the following:

(1) For a pending PMA that involves only contact lenses covered by

this reclassification, the sponsor may ask that its PMA application be

converted, in total, to a 510(k) application.

The amendment to the PMA should include all of the necessary

content requirements for a 510(k), thus making the application as

complete as possible when it is converted to a 510(k). For example, if

an applicant has a pending PMA supplement for a modification to a

previously approved daily wear contact lens, and if this modification

has been identified in the ``Premarket Notification (510(k)) Guidance

Document for Daily Wear Contact Lenses'' as a change requiring

submission of a 510(k), the applicant can amend this PMA with a request

to convert it into a 510(k). PMA's converted to 510(k)'s under this

order will retain their position in the review queue (if they are

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

(2) For a pending PMA that involves both lenses that are covered by

this reclassification and those that are not, the applicant should

withdraw the portion of the application that addresses the reclassified

lenses and resubmit it as a 510(k) application.

For example, if a pending PMA contains a request for a new or

modified lens material for both a daily and extended wear contact lens,

the applicant should withdraw the request for the daily wear lens and

ask the agency to proceed with the review of that portion of the PMA

involving the extended wear contact lens only. Pending PMA's that must,

in part, be resubmitted as a 510(k) application will retain their

position in the review queue if the applicant responds with the

appropriate amendment and clearly states in the amendment that the

daily wear contact lens portion of the PMA will be resubmitted as a

510(k) application.

Whichever option applies, the applicant should determine whether

the previous request involving the daily wear contact lens must be

resubmitted and evaluated through the 510(k) process or be implemented

without the need for submission of a 510(k). To make this

determination, the applicant should consult the 510(k) procedures (21

CFR part 807) and the ``Premarket Notification (510(k)) Guidance

Document for Daily Wear Contact Lenses.'' If the applicant determines

that a 510(k) application is required, the sponsor should resubmit the

application following the content and format requirements for 510(k)

applications. The agency notes that preclinical and clinical data

formerly required in the PMA may still be necessary to support a

substantial equivalence determination. Preclinical and clinical data

which is also contained in a pending PMA may be incorporated by

reference in a 510(k) application. The applicant should include in the

amendment the claim of substantial equivalence to their previously

approved daily wear contact lens and a summary of the safety and

effectiveness information or a statement that the applicant will make

the safety and effectiveness information available to interested

persons upon request.

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) applications before simply converting PMA's to 510(k)

applications since the disclosure regulations may treat information in

the applications differently. For this reason, a manufacturer may

choose not to have the pending PMA converted to a 510(k) application,

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) application.

If an applicant fails to submit an amendment as outlined above

within 180 days, FDA will consider the pending PMA or PMA supplement to

be voluntarily withdrawn. In such cases, the agency will notify the

applicant 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 (address above).

Additional questions regarding the administrative procedures

resulting from this reclassification order should be directed to the

PMA Staff (Kathy Lundsten, 301-594-2186), or to the Division of

Ophthalmic Devices, Contact Lens Branch (David M. Whipple, 301-594-

2205, or James F. Saviola, 301-594-1744).

Dated: February 24, 1994.

Michael R. Taylor,

Deputy Commissioner for Policy.

[FR Doc. 94-4697 Filed 3-3-94; 8:45 am]

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