[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]
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