42310 Federal Register / Vol. 74, No. 161 / Friday, August 21, 2009 / Notices 

C. Target Audience 

The course is targeted at healthcare 

professionals responsible for, or 

involved in, the conduct and/or design 

of clinical trials. 

Dated: August 14, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–20084 Filed 8–20–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0395] 

Draft Guidance for Industry, User 

Facilities, and Food and Drug 

Administration Staff; eMDR— 

Electronic Medical Device Reporting; 

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availability of the draft guidance 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 ‘‘eMDR—Electronic Medical 

Device Reporting.’’ The draft guidance 

document addresses general issues 

related to the submission of postmarket 

medical device reports (MDRs) in 

electronic format. Elsewhere in this 

issue of the Federal Register, FDA is 

publishing a proposed rule to require 

that manufacturers, importers, and user 

facilities submit most MDRs to the 

agency in electronic format. 

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draft guidance by November 19, 2009. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘eMDR—Electronic 

Medical Device Reporting’’ to the 

Division of Small Manufacturers, 

International, and Consumer Assistance 

, Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Building 

66, rm. 4613, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your request, or fax your request to 301– 

847–8149. 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this draft guidance to the Division of 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: 

Howard Press, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Building 66, rm. 3320, Silver 

Spring, MD 20993–0002, 301–796–6087. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The draft guidance document 

provides information related to the 

submission of postmarket MDRs in 

electronic format, including technical 

information. The information provided 

in the draft guidance document is 

intended to help reporters prepare the 

MDR for electronic submission in a way 

that would satisfy the requirements of 

FDA’s proposed electronic Medical 

device reporting regulation that is 

published elsewhere in this issue of the 

Federal Register. 

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 electronic medical device reporting 

(eMDR). 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 an electronic 

copy of ‘‘eMDR—Electronic Medical 

Device Reporting’’ you may either send 

an e-mail request to dsmica@fda.hhs.gov 

or send a fax request to 240–276–3151 

to receive a hard copy. Please use the 

document number 1679 to identify the 

guidance you are requesting. 

The Center for Devices and 

Radiological Health (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 

on the Division of Dockets Management 

Internet site at http:// 

www.regulations.gov. 

IV. Paperwork Reduction Act of 1995 

This draft guidance refers to proposed 

collections of information described in 

FDA’s proposed rule on medical device 

reporting, electronic submission 

requirements, published elsewhere in 

this issue of the Federal Register. The 

proposed collections of information in 

the proposed rule are subject to review 

by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3520). In accordance with the 

proposed medical device regulation, 

medical device manufacturers, 

importers, and user facilities would be 

required to submit MDRs to FDA, to 

maintain records, and may also seek 

exemption or variance from these 

requirements. Manufacturers, importer, 

and user facilities are currently 

submitting paper MDR reports on FDA 

Form 3500 A, for which the existing 

information collection requirements 

under 21 CFR part 803 are approved 

under OMB control number 0910–0437. 

The changes to the burden associated 

with this proposed rule have been sent 

to OMB as a revision to OMB control 

number 0910–0437 for review under 

section 307(d) of the PRA. 

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: August 11, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–19681 Filed 8–20–09; 8:45 am] 

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