[Federal Register Volume 79, Number 78 (Wednesday, April 23, 2014)]
[Notices]
[Pages 22690-22691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-09190]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0090]


Balancing Premarket and Postmarket Data Collection for Devices 
Subject to Premarket Approval; Draft Guidance for Industry and Food and 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 or the Agency) is 
announcing the availability of the draft guidance entitled ``Balancing 
Premarket and Postmarket Data Collection for Devices Subject to 
Premarket Approval.'' This draft guidance clarifies FDA's current 
policy on balancing premarket and postmarket data collection during the 
Agency's review of premarket approval applications (PMA). Specifically, 
this guidance outlines how FDA considers the role of postmarket 
information in determining the appropriate type and amount of data that 
should be collected in the premarket setting to support premarket 
approval, while still meeting the statutory standard of safety and 
effectiveness. FDA believes this guidance will improve patient access 
to safe and effective medical devices that are important to public 
health by improving the predictability, consistency, transparency, and 
efficiency of the premarket process. This draft guidance is not final 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by July 22, 2014.

ADDRESSES: An electronic copy of the guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the draft guidance document entitled 
``Balancing Premarket and Postmarket Data Collection for Devices 
Subject to Premarket Approval'' to the Office of the Center Director, 
Guidance and Policy Development, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, rm. 5431, Silver Spring, MD 20993-0002 or the Office of 
Communication, Outreach and Development (HFM-40), Center for Biologics 
Evaluation and Research, Food and Drug Administration, 1401 Rockville 
Pike, Rockville, MD 20852-1448. Send one self-addressed adhesive label 
to assist that office in processing your request.
    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: Office of the Center Director, Center 
for Devices and Radiological Health, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 66, rm. 5431, Silver Spring, MD 20993-
0002, 301-796-5900 or Stephen Ripley, Center for

[[Page 22691]]

Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA has long applied postmarket controls as a way to reduce 
premarket data collection, where appropriate, while assuring that the 
statutory standard for approval of reasonable assurance of safety and 
effectiveness is still met. The right balance of premarket and 
postmarket data collection facilitates timely patient access to 
important new technology without undermining patient safety.
    In this draft guidance, FDA describes existing statutory 
requirements under the Federal Food, Drug, and Cosmetic Act, its 
implementing regulations, and FDA policies that support the policy on 
balancing premarket and postmarket data collection during review of PMA 
applications. In addition, FDA clarifies how the Agency considers 
postmarket data as part of the benefit-risk framework described in 
FDA's guidance ``Factors to Consider When Making Benefit-Risk 
Determinations in Medical Device Premarket Approval and De Novo 
Classifications,'' issued on March 28, 2012. This guidance provides a 
resource for industry and FDA staff on how FDA determines when it is 
appropriate for a sponsor of a PMA to collect some data (clinical or 
non-clinical) in the postmarket setting, rather than premarket.
    Elsewhere in this issue of the Federal Register, FDA is announcing 
another draft guidance entitled ``Expedited Access for Premarket 
Approval Medical Devices Intended for Unmet Medical Need for Life 
Threatening or Irreversibly Debilitating Diseases or Conditions,'' 
which also addresses the role of postmarket data and the benefit-risk 
framework as key elements of FDA's proposed ``Expedited Access 
Program.''

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 balancing 
premarket and postmarket data collection for devices subject to 
premarket approval. 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 downloading an electronic copy from the Internet. A search 
capability for all Center for Devices and Radiological Health guidance 
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov or http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to 
download an electronic copy of ``Balancing Premarket and Postmarket 
Data Collection for Devices Subject to Premarket Approval,'' may send 
an email request to [email protected] to receive an electronic 
copy of the document. Please use the document number 1833 to identify 
the guidance you are requesting.

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 (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 820 have been approved under 
OMB control number 0910-0073; and the collections of information in 21 
CFR part 822 have been approved under OMB control number 0910-0449.

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: April 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09190 Filed 4-22-14; 8:45 am]
BILLING CODE 4160-01-P