
[Federal Register Volume 80, Number 70 (Monday, April 13, 2015)]
[Notices]
[Pages 19672-19673]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-08363]


-----------------------------------------------------------------------

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; Guidance for Industry and Food and Drug 
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Balancing Premarket and 
Postmarket Data Collection for Devices Subject to Premarket Approval.'' 
This 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.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

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 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 to the Office of 
Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your request.
    Submit electronic comments on the 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: Aaron Josephson, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5449, Silver Spring, MD 20993-0002, 301-
796-5178; or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 7301, Silver Spring, MD 20993-0002.

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 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 PMAs. 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.
    A draft of this guidance was made available in the Federal Register 
on April 23, 2014, and the comment period closed July 22, 2014. Changes 
between the draft and final versions of this guidance include an 
increased focus on patient outcomes and additional examples to help 
industry better understand when it may be appropriate to shift data 
collection from the premarket to postmarket setting. The final guidance 
also recognizes the potential for use of registry data to satisfy post-
approval study requirements.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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 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 from CBER 
at 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 CDRH-Guidance@fda.hhs.gov to receive an electronic 
copy of the document. Please use the document number 1833 to

[[Page 19673]]

identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This 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 801 have been approved under 
OMB control number 0910-0485; the collections of information in 21 CFR 
part 803 have been approved under OMB control number 0910-0437; the 
collections of information in 21 CFR part 812 have been approved under 
OMB control number 0910-0073; the collections of information in 21 CFR 
part 822 have been approved under OMB control number 0910-0449; the 
collection of information in 21 CFR part 860, subpart C have been 
approved under OMB control number 0910-0138; and the collections of 
information in the guidance document regarding requests for feedback on 
medical device submission have been approved under OMB control number 
0910-0756.

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 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-08363 Filed 4-10-15; 8:45 am]
 BILLING CODE 4164-01-P


