[Federal Register Volume 77, Number 169 (Thursday, August 30, 2012)]
[Notices]
[Pages 52745-52746]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-21437]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0361]
Leveraging Registries With Medical Device Data for Postmarket
Surveillance and Evidence Appraisal Throughout the Total Product Life
Cycle
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
following public workshop entitled ``Leveraging Registries With Medical
Device Data for Postmarket Surveillance and Evidence Appraisal
Throughout the Total Product Life Cycle.'' The topic to be discussed is
best practices for use of registries with medical device data for
postmarket surveillance, clinical studies, and evidence appraisal.
DATES: The public workshop will be held on September 12, 2012, from 8
a.m. to 5 p.m. and September 13, 2012, from 8 a.m. to 5 p.m.
ADDRESSES: The public workshop will be held at the Greenbelt Marriott
Hotel, 6400 Ivy Lane, Greenbelt, MD 20770, 301-441-3700.
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, 301-
796-6689, email: Danica.Marinac-Dabic@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Registration: Registration is free and on a first-come, first-
served basis. Persons interested in attending this public workshop must
register online by 5 p.m., September 10, 2012. Early registration is
recommended because facilities are limited and, therefore, FDA may
limit the number of participants from each organization. Onsite
registration will not be available on the day of the workshop.
If you need special accommodations due to disability, please
contact Cynthia Garris, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
4321, Silver Spring, MD 20993, 301-796-5861, email:
cynthia.garris@fda.hhs.gov; no later than September 5, 2012.
To register for the public workshop, please visit FDA's Medical
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
(Select this public workshop from the posted events list.) Please
provide complete contact information for each attendee, including name,
title, affiliation, address, email, and telephone number. Those without
Internet access should contact Danica Marinac-Dabic (see Contact
Person). Registrants will receive confirmation after they have been
accepted. You will be notified if you are on a waiting list.
Streaming Webcast of the Public Workshop: This public workshop will
also be Webcast. Persons interested in viewing the Webcast must
register online by 5 p.m., September 5, 2012. Early registration is
recommended because Webcast connections are limited. Organizations are
requested to register all participants but to view using one connection
per location. Webcast participants will be sent technical system
requirements after registration and will be sent connection access
information after September 7, 2012.
Comments: FDA is holding this public workshop to obtain information
on best practices for use of registries with medical device data for
postmarket surveillance, clinical studies, and evidence appraisal. In
order to permit the widest possible opportunity to obtain public
comment, FDA is soliciting either electronic or written comments on all
aspects of the workshop topics. The deadline for submitting comments
related to this public workshop is October 10, 2012.
Regardless of attendance at the meeting, interested persons may
submit either written comments regarding this document to the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852 or electronic comments to
http://www.regulations.gov. 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. In addition, when responding to specific
questions as outlined in section II of this document, please identify
the question you are addressing. 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.
Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management (see Comments). A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to the Division of Freedom of Information (ELEM-1029),
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857. A link to the transcripts will also be available
approximately 45 days after the public workshop on the Internet at
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.)
[[Page 52746]]
I. Background
Registries with medical device data collect data on patients who
have been exposed to a medical device. Medical device postmarket
surveillance presents unique challenges, related to the diversity and
complexity of these products, the iterative nature of product
development, the learning curve associated with technology adoption,
and the relatively short, product life-cycle. For these reasons, FDA's
Center for Devices and Radiological Health (CDRH) uses registries to
assess the real-world performance of medical products and procedures;
to determine the clinical effectiveness and safety of a test, medical
device, procedure, or treatment; to describe the natural history of a
problem or disease; and to examine trends of disease, treatment, or
product use over time.
To be useful for postmarket device surveillance and assessment of
benefits and risks, registries must contain sufficiently detailed
patient, device, and procedural data and be linked to meaningful
clinical outcomes. CDRH currently engages with more than a dozen
registry efforts across a number of device areas, including
cardiovascular, orthopedic, ophthalmic, and general surgery products.
However, it is not practical or feasible to establish registries for
each individual medical device. Development and maintenance of
registries with medical device data and consortia of registries needs
to be strategic, focused on product areas of high importance, utilize
methodologies that integrate data collection into clinical practice,
and maximize robust data collection while minimizing resource
intensity.
CDRH believes that registry development in targeted product areas
will both provide needed postmarket data to enhance public health and
be cost-effective for industry, health care providers, and payers. In
order to best leverage use of registries with medical device data,
participation from all stakeholders, including other government
Agencies, academia, professional societies, health care industry
organizations, and patient and consumer groups, is needed. The purpose
of the public workshop is to facilitate discussion among these key
stakeholders in the scientific community on issues related to best
practices for medical device registries for use across the Total
Product Life Cycle. This public workshop is open to all interested
parties. The target audience is professionals in general (academic,
healthcare, payers, industry) interested in leveraging registries with
medical device data as data and infrastructure for surveillance and
studies.
II. Topics for Discussion at the Public Workshop
We intend to discuss a large number of issues at the public
workshop, including but not limited to the following: (1) Current
utilization of registries with medical device data; (2) use of
registries with medical device data for postmarket surveillance; (3)
registries in relation to the Sentinel provision in the FDA Safety and
Innovation Act calling for the expansion of the postmarket risk
identification and analysis system to include devices; (4) challenges
and opportunities for using registries with medical device data for
regulated studies; (5) best practices for governance and structure of
registries; (6) business models for sustainable efforts; and (7)
strategies and priorities for future use of registries with medical
device data.
Dated: August 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-21437 Filed 8-27-12; 4:15 pm]
BILLING CODE 4160-01-P