[Federal Register Volume 80, Number 37 (Wednesday, February 25, 2015)]
[Notices]
[Pages 10125-10126]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

[[Page 10126]]


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 protected].

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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