[Federal Register Volume 80, Number 164 (Tuesday, August 25, 2015)]
[Notices]
[Pages 51567-51568]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20948]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2048]


Medical Device Epidemiology Network Registry Task Force 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 ``Recommendations for a National Medical 
Device Evaluation System: Strategically Coordinated Registry Networks 
to Bridge the Clinical Care and Research,'' developed by the Medical 
Device Epidemiology Network's Medical Device Registry Task Force. In 
addition, FDA has established a docket where stakeholders may provide 
comments.

DATES: Submit either electronic or written comments by October 26, 
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: Danica Marinac-Dabic, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 4110, Silver Spring, MD 20993-0002, 
301-796-6689, 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 and radiation-emitting products. A key part of this 
mission is to monitor medical devices and radiological products 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

[[Page 51568]]

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 Medical Device Registry Task Force to promote the 
development of national and international device registries for 
selected products (Ref. 1). Under a cooperative agreement with the FDA, 
Duke University convened the Medical Device Registry Task Force as a 
part of the Medical Device Epidemiology Network public-private 
partnership in 2014. The Task Force membership included representatives 
from a broad array of stakeholder groups and areas of expertise 
including patients, provider organizations, hospitals, health plans, 
industry, government agencies, as well as methodologists and academic 
researchers.
    The Medical Device Registry Task Force was charged to: (1) Identify 
existing registries that may contribute to the system; (2) leverage 
ongoing registry efforts focused on quality improvement, reimbursement, 
patient-centered outcomes and other activities to best meet the needs 
of multiple stakeholders; (3) identify priority medical device types 
for which the establishment of a longitudinal registry is of 
significant public health importance; (4) define registry governance 
and data quality practices that promote rigorous design, conduct, 
analysis, and transparency to meet stakeholder needs; and (5) develop 
strategies for the use of registries to support premarket approval and 
clearance (Ref. 1).
    This notice announces the availability and Web site location of the 
Medical Device Registry Task Force's report, entitled ``Recommendations 
for a National Medical Device Evaluation System: Strategically 
Coordinated Registry Networks to Bridge the Clinical Care and 
Research.'' 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. To access ``Recommendations 
for a National Medical Device Evaluation System: Strategically 
Coordinated Registry Networks to Bridge the Clinical Care and 
Research'' report, visit 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.

III. Reference

    The following reference has been placed on display in the Division 
of Dockets Management (see ADDRESSES) and may be seen by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday. We have 
verified the Web site address, but we are not responsible for 
subsequent changes to the Web site after this document publishes in the 
Federal Register.

    1. ``Strengthening Our National System for Medical Device 
Postmarket Surveillance: Update and Next Steps,'' April 2013, 
available at http://www.fda.gov/downloads/MedicalDevices/Safety/CDRHPostmarketSurveillance/UCM348845.pdf.

    Dated: August 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20948 Filed 8-24-15; 8:45 am]
 BILLING CODE 4164-01-P