[Federal Register Volume 64, Number 198 (Thursday, October 14, 1999)]
[Notices]
[Pages 55735-55736]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-26719]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-4054]
Draft Guidance for Industry on Intraocular Lens; Availability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availability of the draft guidance entitled ``Intraocular Lens Guidance
Document.'' This draft guidance is not final nor is it in effect at
this time. This draft guidance describes preclinical and clinical
requirements that may be used in support of investigational device
exemptions, premarket approval applications, and product development
protocols. This draft guidance describes for industry and FDA reviewers
the type of information needed to support investigational and marketing
applications for intraocular lenses.
DATES: Written comments concerning this guidance must be received by
January 12, 2000.
ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of the draft guidance entitled ``Intraocular Lens Guidance
Document'' to the Division of Small Manufacturers Assistance (HFZ-220),
Center for Devices and Radiological Health, Food and Drug
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-
addressed adhesive labels to assist that office in processing your
request, or fax your request to 301-443-8818. Written comments
concerning this draft guidance must be submitted to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. Comments should be identified with
the docket number found in the brackets in the heading of this
document. See the SUPPLEMENTARY INFORMATION section for information on
electronic access to this draft guidance.
FOR FURTHER INFORMATION CONTACT: Donna R. Lochner, Center for Devices
and Radiological Health (HFZ-463), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2053.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance entitled
``Intracular Lens Guidance Document.'' This draft guidance provides
detailed information about the type of preclinical testing needed to
support both a clinical investigation and marketing applications for
new intraocular lenses and modifications to intraocular lenses. This
draft guidance also provides the basic principles that should be
applied in the conduct of a clinical study for new or modified
intraocular lenses. Earlier revisions of this draft guidance have been
discussed in numerous forums since April of 1997, and industry,
clinicians, and other interested parties have participated. These
forums have included at least three Ophthalmic Device Panel meetings at
which this draft guidance, or parts of the guidance, have been
discussed. These Panel discussions began before 1997, and most recently
they occurred in October 1997. Both written and verbal comments have
been received and discussed thoroughly in these forums.
Although this draft guidance, to a large extent, describes review
elements that have been in existence since almost the inception of
FDA's review of intraocular lenses, it has been refined and improved
through the interactive discussions with the industry, clinicians,
panel members, and other interested parties. FDA has made available to
all interested parties a summary of all written comments received, and
on each version of the guidance FDA has noted the changes from the
previous version. This information is available for this most recent
release and for previous revisions. Interested persons may obtain this
information through the contact person at the address and phone number
given above.
II. Significance of Guidance
This draft guidance document represents the agency's current
thinking on submissions for intraocular lenses. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statute, regulations, or
both.
The agency has adopted Good Guidance Practices (GGP's), which set
forth the agency's policies and procedures for the development,
issuance, and use of guidance documents (62 FR 8961, February 27,
1997). This guidance document is
[[Page 55736]]
issued as a Level 1 guidance consistent with GGP's.
III. Electronic Access
In order to receive the ``Intraocular Lens Guidance Document'' via
your fax machine, call the CDRH Facts-On-Demand (FOD) system at 800-
899-0381 or 301-827-0111 from a touch-tone telephone. At the first
voice prompt press 1 to access DSMA Facts, at second voice prompt press
2, and then enter the document number (834) followed by the pound sign
(#). Then follow the remaining voice prompts to complete your request.
Persons interested in obtaining a copy of the guidance may also do
so using the World Wide Web (WWW). The Center for Devices and
Radiological Health (CDRH) maintains an entry on the WWW for easy
access to information, including text, graphics, and files that may be
downloaded to a personal computer with access to the WWW. Updated on a
regular basis, the CDRH Home Page includes the ``Intraocular Lens
Guidance Document,'' device safety alerts, Federal Register reprints,
information on premarket submissions (including lists of approved
applications and manufacturers' addresses), small manufacturers'
assistance, information on video conferencing and electronic
submissions, mammography matters, and other device-oriented
information. The CDRH home page may be accessed at ``http://
www.fda.gov/cdrh''. The ``Intraocular Lens Guidance Document'' will be
available at ``http://www.fda.gov/cdrh/ode/iol-guidance.pds''.
IV. Comments
Interested persons may, on or before January 12, 2000, submit to
Dockets Management Branch (address above) written comments regarding
this 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. The draft guidance and received comments may be seen in
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through
Friday.
Dated: September 29, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 99-26719 Filed 10-13-99; 8:45 am]
BILLING CODE 4160-01-F