Draft Guidance for Industry on Refractive Implants: Investigational Device Exemptions (IDE's) and Premarket Approval Applications (PMA's); Availability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.

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The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Refractive Implants: Investigational Device Exemptions (IDE's) and Premarket Approval Applications (PMA's).”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 This draft guidance describes preclinical and clinical information that may be used in support of IDE's and PMA's.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Submit written requests for single copies on a 3.5″ diskette of the draft guidance entitled “Refractive Implants: Investigational Device Exemptions (IDE's) and Premarket Approval Applications (PMA's)” to the Division of Small Manufacturers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 See the SUPPLEMENTARY INFORMATION section for information on electronic access to the draft guidance.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FDA is announcing the availability of a draft guidance entitled “Refractive Implants: Investigational Device Exemptions (IDE's) and Premarket Approval Applications (PMA's).” This draft guidance is intended to provide detailed information about the type of preclinical testing that can support both clinical investigations and marketing applications for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 This draft guidance also is intended to provide the basic principles that should be applied in the conduct of a clinical study for refractive implants.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.