Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Investigational Device Exemption (IDE) Guidance for Retinal Prostheses.” This draft guidance document provides recommendations to industry about developing pre-clinical and clinical tests of retinal prosthetic devices for submission to FDA in an IDE application. This draft guidance is not final nor is it in effect at this time.
Although you can comment on any guidance at any time (see 21 CFR 10.115 (g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by July 16, 2009.
Submit written requests for single copies of the draft guidance document entitled “Investigational Device Exemption (IDE) Guidance for Retinal Prostheses” to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850.
Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 240-276-3151. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance.
Submit written comments concerning this draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. Identify comments with the docket number found in brackets in the heading of this document.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Everette T. Beers, Center for Devices and Radiological Health, HFZ-460, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4200.End Further Info End Preamble Start Supplemental Information
A retinal prosthesis is a visual prosthetic device, implanted on or beneath the retina or on the outer surface of the globe, that uses electrical stimulation to provide some level of visual stimulation for persons suffering from degenerative retinal conditions. This draft guidance helps device manufacturers submit an IDE to FDA so that they may conduct feasibility and/or pivotal human clinical trials of their retinal prostheses in the United States in order to support a premarket approval application (PMA). The draft guidance provides recommendations about pre-clinical and clinical tests of retinal prosthetic devices. The draft guidance does not apply to prostheses that stimulate the optic nerve or other higher brain areas such as the visual cortex or the lateral geniculate nucleus.
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized will represent the agency's current thinking on investigational device exemption (IDE) applications for retinal prostheses. 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 and regulations.
III. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. To receive “Investigational Device Exemption (IDE) Guidance for Retinal Prostheses,” you may either send an e-mail request to firstname.lastname@example.org to receive an electronic copy of the document or send a fax request to 240-276-3151 to receive a hard copy. Please use the document number 1651 to identify the guidance you are requesting.
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 Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, Federal Register reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturer's assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at http://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also available at http://www.regulations.gov.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 812 have been approved under OMB control number 0910-0078; collections of information in 21 CFR parts 50 and 56 have been approved under OMB control number 0910-0130; and collections of information in 21 CFR part 814, subpart E, have been approved under OMB control number 0910-0231.
Interested persons may submit to the Division of Dockets Management (see ADDRESSES), written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper 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 Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.Start Signature
Dated: February 11, 2009.
Associate Commissioner for Policy and Planning.
[FR Doc. E9-8774 Filed 4-16-09; 8:45 am]
BILLING CODE 4160-01-S