17872 Federal Register / Vol. 74, No. 73 / Friday, April 17, 2009 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0010] 

Draft Guidance for Industry and Food 

and Drug Administration Staff; 

Investigational Device Exemption 

Guidance for Retinal Prostheses; 

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availability of the draft guidance 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 ‘‘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 This draft guidance 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 This draft guidance is not 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. 

DATES: 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draft guidance by July 16, 2009. 

ADDRESSES: 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single copies of the draft guidance 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this draft guidance to the Division of 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. 

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. 

SUPPLEMENTARY INFORMATION: 

I. Background 

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 

dsmica@fda.hhs.gov 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. 

V. Comments 

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. 

Dated: February 11, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–8774 Filed 4–16–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0126] 

Draft Guidance for Industry on the 

Submission of Summary 

Bioequivalence Data for Abbreviated 

New Drug Applications; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

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