Medical Devices; Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products; Draft; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Docket No. 95D-0399]

Medical Devices; Premarket Notification (510(k)) Guidance

Document for Contact Lens Care Products; Draft; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the

availability of a draft guidance entitled ``Premarket Notification

(510(k)) Guidance Document for Contact Lens Care Products.'' The draft

guidance accompanies a proposed rule to reclassify rigid gas permeable

contact lens solution; soft (hydrophilic) contact lens solution; and

contact lens heat disinfecting units from class III (premarket

approval) to class II (special controls), which appears elsewhere in

this issue of the Federal Register. The draft guidance sets forth the

tests FDA's Center for Devices and Radiological Health (CDRH) believes

necessary to provide reasonable assurance of the safety and

effectiveness of these devices. The draft guidance also sets forth the

evidence that FDA believes should be submitted to demonstrate the

substantial equivalence of new contact lens care products to contact

lens care products already marketed.

DATES: Submit written comments by May 31, 1996.

ADDRESSES: Submit written requests for single copies of the draft

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

for Contact Lens Care Products'' to the Division of Small Manufacturers

Assistance (HFZ-22O), CDRH, Food and Drug Administration, 1350 Piccard

Dr., Rockville, MD 20850, 301-443-6597 (outside MD 1-800-638-2041).

Send two self-addressed adhesive labels to assist the office in

processing your requests. Submit written comments on the draft guidance

to the Dockets Management Branch (HFA-305), Food and Drug

Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

Requests and comments should be identified with the docket number found

in brackets in the heading of this document. The draft guidance and

received comments are available for public examination in the Dockets

Management Branch (address above) 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, 9200

Corporate Blvd., Rockville, MD 20850, 301-594-2205.

SUPPLEMENTARY INFORMATION:

I. The Statutory Requirements

The Safe Medical Devices Act (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 et. seq.), contains specific

provisions on transitional devices (i.e., those devices regulated as

new 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 rigid

gas permeable contact lens solutions; soft (hydrophilic) contact lens

solutions; and contact lens heat disinfecting units into class III

(premarket approval). 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 to direct FDA to collect certain

safety and effectiveness information from the manufacturers of

transitional devices and review the classification of those

transitional devices that still remained in class III to determine if

the devices should be reclassified into 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 classification down to class

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

act, in the Federal 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 regulations before the December 1, 1993 deadline.

Nevertheless, elsewhere in this issue of the Federal Register, FDA is

proposing to reclassify from class III (premarket approval) to class II

(special controls) all transitional contact lens care products. In

conjunction with the proposed

[[Page 14331]]

reclassification, FDA is announcing the availability of the draft

guidance for premarket notification for the proposed reclassified

contact lens care products entitled ``Premarket Notification (510(k))

Guidance Document for Contact Lens Care Products.''

II. The Draft Guidance

The draft guidance sets forth the testing that FDA believes ensures

the continued safety and effectiveness of transitional contact lens

care products. It also provides comprehensive directions to enable a

manufacturer of a contact lens care product to submit a 510(k)

premarket notification demonstrating substantial equivalence of the

device to a legally marketed contact lens care product (predicate

device). Information on the battery of preclinical testing that may

demonstrate substantial equivalence is included in the guidance. If the

results of preclinical testing demonstrate that the device will 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 the investigational

protocol.

The draft guidance also outlines the types of manufacturing and

chemistry, toxicology, and microbiology testing that should be

completed for each device, and a summary of the basic requirements and

suggested methods for meeting these preclinical requirements. Other

elements of the draft guidance include: (1) General information on the

regulations and requirements for labeling contact lens care products;

(2) information about 510(k) requirements relating to modifying a

marketed contact lens care product; and (3) guidance for submitting a

510(k) for contact lens cases and contact lens accessories (i.e.,

mechanical cleaning aids and accessory cleaning pads).

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 most contact lens care

products to be nonsignificant risk investigations. For nonsignificant

risk investigations, approval of an institutional review board (IRB) is

necessary before initiating a clinical study, and an investigational

plan and informed consent document must be presented to an IRB for

review and approval. Prior FDA approval is not required. However, FDA

considers most clinical studies of solutions that contain new active

ingredients for ophthalmic use and are intended for use directly in the

eye to be significant risk investigations that would require both IRB

and FDA review and approval.

This draft guidance will be discussed at a future 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.

III. Significance of a Guidance

In the past, guidances have generally been issued under

Sec. 10.90(b) (21 CFR 10.90(b)), which provides for the use of

guidances to state procedures or standards of general applicability

that are not legal requirements, but that are acceptable to FDA. The

agency is now in the process of revising Sec. 10.90(b). Therefore, this

draft guidance is not being issued under the authority of

Sec. 10.90(b). Although this guidance does not create or confer any

rights on any person, and does not operate to bind FDA in any way, it

does represent FDA's current thinking on the tests the agency believes

necessary to provide reasonable assurance of the safety and

effectiveness of transitional contact lens care products.

IV. Requests for Comments

Interested persons may, on or before May 31, 1996, submit to the

Dockets Management Branch (address above) written comments regarding

the draft guidance. Two copies of any comments are to be submitted,

except that individuals may submit one copy. Comments are to be

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

this document. Received comments may be seen in the office above

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

will be considered in determining whether to amend the current draft

guidance.

Dated: March 18, 1996.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center for Devices and

Radiological Health.

[FR Doc. 96-7834 Filed 3-29-96; 8:45 am]

BILLING CODE 4160-01-F