[Federal Register Volume 61, Number 63 (Monday, April 1, 1996)]
[Notices]
[Pages 14330-14331]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7834]



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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.

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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availability of a draft guidance entitled ``Premarket Notification 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 The draft 
guidance accompanies a proposed rule to reclassify rigid gas permeable 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 The draft guidance sets forth the 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 The draft guidance also sets forth the 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ADDRESSES: Submit written requests for single copies of the draft 
guidance entitled ``Premarket Notification (510(k)) Guidance Document 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 Submit written comments on the draft guidance 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 The draft guidance and 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