[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Draft Guidance for Industry on Intraocular Lens; Availability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availability of the draft guidance entitled ``Intraocular Lens Guidance 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 This draft guidance is not final nor is it in effect at 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 This draft guidance describes preclinical and clinical 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 This draft guidance describes for industry and FDA reviewers 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diskette of the draft guidance entitled ``Intraocular Lens Guidance 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concerning this draft guidance must be submitted to the Dockets 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electronic access to this draft guidance.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     FDA is announcing the availability of a draft guidance entitled 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 This draft guidance provides 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