[Federal Register Volume 80, Number 37 (Wednesday, February 25, 2015)]
[Notices]
[Pages 10125-10126]
[FR Doc No: 2015-03886]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0359]

National Medical Device Postmarket Surveillance System Planning
Board Report; Availability, Web Site Location and Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the report and Web site location where the Agency has
posted the report entitled ``Strengthening Patient Care: Building an
Effective National Medical Device Surveillance System,'' developed by
the National Medical Device Postmarket Surveillance System Planning
Board. In addition, FDA has established a docket where stakeholders may
provide comments.

DATES: Submit either electronic or written comments by April 27, 2015.

ADDRESSES: Submit electronic comments on this document 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: Thomas P. Gross, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 2316, Silver Spring, MD 20993-0002, 301-
796-5700, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA's Center for Devices and Radiological Health is responsible for
protecting the public health by assuring the safety and effectiveness
of medical devices. A key part of this mission is to monitor medical
devices for continued safety and effectiveness after they are in use
and to help the public get the accurate, science-based information they
need to improve their health.
    In September 2012, the FDA published a report, ``Strengthening Our
National System for Medical Device Postmarket Surveillance,'' that
proposed a strategy for improving the current system for monitoring
medical device safety and effectiveness. In April 2013, the FDA issued
an update to the September 2012 report that incorporated public input
received and described the next steps towards fulfilling the vision for
building a national postmarket surveillance system. These reports can
be found at FDA's Web site http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/ucm301912.htm.
    One of these next steps consisted of establishing a
multistakeholder planning board to identify the governance structure,
practices, policies, procedures, methodological approaches, and
business model(s) necessary to facilitate the creation of a
sustainable, integrated medical device postmarket surveillance system
that leverages and complements existing and ongoing efforts. Under a
cooperative agreement with the FDA, the Engelberg Center for Health
Care Reform at the Brookings Institution convened the National Medical
Device Postmarket Surveillance Planning Board (the Planning Board) in
2014. The Planning Board membership included representatives from a
broad array of stakeholder groups and areas of expertise including
patients, provider organizations, hospitals, health plans, industry,
and government agencies, as well as methodologists and academic
researchers.
    The Planning Board was tasked with developing a set of long-term
principles and priorities for a National Postmarket Surveillance
System. The task included identifying potential governance and business
models that address legal and privacy considerations, system financing
and stability, mechanisms to support the appropriate use of data, and
policies to ensure system transparency. The Planning Board was also
asked to provide recommendations about how to leverage the system to
meet the needs of other medical device stakeholders and groups seeking
to develop better evidence (http://www.brookings.edu/about/centers/health/call-for-nominations and https://dcri.org/events/past-meetings/MDEpiNet-nominations).
    This notice announces the availability and Web site location of the
Planning Board's report entitled ``Strengthening Patient Care: Building
an Effective National Medical Device Surveillance System.'' FDA invites
interested persons to submit comments on this report. We have
established a docket where comments may be submitted (see ADDRESSES).
We believe this docket is an important tool for receiving feedback on
this report from interested parties and for sharing this information
with the public. The report ``Strengthening Patient Care: Building an
Effective National Medical Device Surveillance System'' can be found at
FDA's Web site http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/ucm301912.htm.

II. Request for 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: February 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03886 Filed 2-24-15; 8:45 am]
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