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availability of a draft guidance entitled ``Premarket Notification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 The draft
guidance accompanies a proposed rule to reclassify rigid gas permeable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 The draft guidance sets forth the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 The draft guidance also sets forth the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ADDRESSES: Submit written requests for single copies of the draft
guidance entitled ``Premarket Notification (510(k)) Guidance Document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 Submit written comments on the draft guidance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 The draft guidance and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