[Federal Register Volume 65, Number 148 (Tuesday, August 1, 2000)]
[Notices]
[Page 46938]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-19337]



[[Page 46938]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1385]


Draft Guidance for Industry on Refractive Implants: 
Investigational Device Exemptions (IDE's) and Premarket Approval 
Applications (PMA's); 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availability of the draft guidance entitled ``Refractive Implants: 
Investigational Device Exemptions (IDE's) and Premarket Approval 
Applications (PMA's).'' This guidance is neither final nor in effect at 
this time. This draft guidance describes preclinical and clinical 
information that may be used in support of IDE's and PMA's.

DATES: Submit written comments concerning this guidance by October 30, 
2000.

ADDRESSES: Submit written requests for single copies on a 3.5" diskette 
of the draft guidance entitled ``Refractive Implants: Investigational 
Device Exemptions (IDE's) and Premarket Approval Applications (PMA's)'' 
to the Division of Small Manufacturers Assistance (HFZ-220), Center for 
Devices and Radiological Health (CDRH), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Send two self-
addressed adhesive labels to assist that office in processing your 
request, or fax your request to 301-443-8818. Submit written comments 
concerning this guidance 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 
brackets in the heading of this document. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the draft 
guidance.

FOR FURTHER INFORMATION CONTACT: Ashley A. Boulware, Center for Devices 
and Radiological Health (HFZ-460), 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    FDA is announcing the availability of a draft guidance entitled 
``Refractive Implants: Investigational Device Exemptions (IDE's) and 
Premarket Approval Applications (PMA's).'' This draft guidance is 
intended to provide detailed information about the type of preclinical 
testing that can support both clinical investigations and marketing 
applications for new refractive implants. This draft guidance also is 
intended to provide the basic principles that should be applied in the 
conduct of a clinical study for refractive implants. Parts of this 
guidance document were discussed at an Ophthalmic Devices Panel meeting 
in October 1998.

II. Significance of Guidance

    This guidance document represents the agency's current thinking on 
submissions for refractive implants. 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 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 issued as a Level 1 guidance 
consistent with GGP's.

III. Electronic Access

    In order to receive ``Refractive Implants: Investigational Device 
Exemptions (IDE's) and Premarket Approval Applications (PMA's)'' 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 (1145) followed by the pound sign 
(#). Then follow the remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the draft guidance may 
also do so using the Internet. CDRH maintains an entry on the Internet 
for easy access to information including text, graphics, and files that 
may be downloaded to a personal computer with access to the Internet. 
Updated on a regular basis, the CDRH home page includes ``Refractive 
Implants: Investigational Device Exemptions (IDE's) and Premarket 
Approval Applications (PMA's),'' 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. ``Refractive Implants: Investigational Device Exemptions (IDE's) 
and Premarket Approval Applications (PMA's)'' is available at http://www.fda.gov/cdrh/ode/guidance/1145.pdf.

IV. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding this draft guidance by 
October 30, 2000. 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 are available 
for public examination in the Dockets Management Branch between 9 a.m. 
and 4 p.m., Monday through Friday.

    Dated: July 17, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-19337 Filed 7-31-00; 8:45 am]
BILLING CODE 4160-01-F