
[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


