[Federal Register Volume 78, Number 220 (Thursday, November 14, 2013)]
[Notices]
[Pages 68459-68460]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-27233]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1279]


Medical Device Development Tools; Draft Guidance for Industry, 
Tool Developers, and Food and Drug Administration Staff; 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availability of the draft guidance entitled ``Medical Device 
Development Tools.'' This document provides guidance to FDA staff, 
industry, healthcare providers, researchers, and patient and consumer 
groups on a new voluntary process within the Center for Devices and 
Radiological Health (CDRH) for qualification of medical device 
development tools (MDDT) for use in device development and evaluation 
programs. This draft guidance is not final nor is it in effect at this 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by February 12, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Medical Device Development Tools'' to the 
Division of Small Manufacturers, International and Consumer Assistance, 
Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 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    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Kathryn O'Callaghan, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 3614, Silver Spring, MD 20993-0002, 
301-796-6349.

SUPPLEMENTARY INFORMATION: 

I. Background

    The draft guidance describes the framework and process for the 
voluntary CDRH qualification of MDDT, including definitions of 
applicable terms, criteria for evaluating an MDDT for a specific 
context of use, the threshold for qualification, and the contents of a 
qualification submission. The intent of this voluntary qualification 
policy is to: (1) Enable faster, more efficient development of 
important life-saving and health-promoting medical devices; (2) promote 
the development of tools to facilitate more timely device evaluation; 
(3) provide a mechanism to better leverage advances in regulatory 
science; and (4) more quickly and more clearly communicate with CDRH 
stakeholders about important advances in regulatory science that may be 
leveraged to speed device development and regulatory evaluation. CDRH 
expects the qualification process to expedite development of publicly 
available tools which could potentially be used widely in multiple 
device development programs. Once an MDDT is qualified for a specific 
context of use, it can be used by any medical device developer for that 
context of use.
    At some point in the future, FDA may initiate a pilot program for 
MDDT qualification submissions, which would help inform final guidance 
on this topic. FDA would publicly announce such a program prior to 
initiation.
    This guidance does not discuss the review of MDDTs submitted as 
part of a specific medical device regulatory submission, nor does it 
address the specific evidentiary standards or performance requirements 
needed for purposes of qualification of a specific MDDT.

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 the 
qualification of MDDTs. 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. A search capability for all

[[Page 68460]]

CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov. To receive ``Medical Device Development Tools,'' 
you may either send an email request to [email protected] to receive 
an electronic copy of the document or send a fax request to 301-847-
8149 to receive a hard copy. Please use the document number 1882 to 
identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance contains information collection that is subject 
to review by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections 
of information in 21 CFR part 812 have been approved under OMB control 
number 0910-0078; the collections of information in 21 CFR part 814 
have been approved under OMB control number 0910-0231; the collections 
of information in 21 CFR part 807 subpart E have been approved under 
OMB control number 0910-0120; and the collections of information in 21 
CFR part 809 have been approved under OMB control number 0910-0485.

V. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments 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, and will be posted to the docket at http://www.regulations.gov.

    Dated: November 4, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-27233 Filed 11-13-13; 8:45 am]
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