[Federal Register Volume 74, Number 249 (Wednesday, December 30, 2009)]
[Notices]
[Pages 69125-69126]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-30871]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
Medical Device Interoperability; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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The Food and Drug Administration (FDA), Center for Devices and
Radiological Health, in co-sponsorship with Continua Health Alliance
and the Center for Integration of Medicine & Innovative Technology
(CIMIT) is announcing a public workshop entitled ``Medical Device
Interoperability.'' The purpose of the workshop is to facilitate
discussion among FDA, industry, academia, professional societies,
clinical investigators and other interested parties on issues related
to safe and effective interoperable medical devices.
Dates and Times: The public workshop will be held on January 25 and
26, 2010, from 9 a.m. to 5 p.m. and on January 27, 2010, from 9 a.m. to
12 noon. Participants are encouraged to arrive early to ensure time for
parking and security screening before the meeting. Security screening
will begin at 8 a.m. and registration will begin at 8:30 a.m.
Location: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Silver Spring, MD 20993.
Contact Persons: Sandy Weininger, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., WO62/rm. 4212, Silver Spring, MD 20993, 301-796-2582,
[email protected]; or John Murray, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., WO66/rm. 2634, Silver Spring, MD 20993, 301-796-5543,
[email protected].
Registration: To register for the public workshop, please visit the
following Web site: http://mdpnp.org/FDA_Interop_Workshop.php. There
is a registration fee of $500 to attend the public workshop to cover
the expenses and attendees must register in advance. The registration
process will be handled by Continua Health Alliance. In person,
attendance is limited to 200 participants.
Registration may be limited to achieve balanced participation. Upon
registering, you will receive a notice indicating that your
registration has been received and is pending confirmation. You will
receive an additional email within 1 week notifying you if your
registration was accepted or declined. You may also register to attend
the public workshop via Web cast for a reduced fee.
Non-U.S. citizens are subject to additional security screening, and
they should register as soon as possible. If you need special
accommodations because of a disability, please contact Susana Rosales
([email protected]) at least 7 days before the public
workshop.
SUPPLEMENTARY INFORMATION:
I. Why Are We Holding This Public Workshop?
The purpose of the public workshop is to facilitate discussion
among FDA and other interested parties regarding the safety and
effectiveness of interoperable medical devices.
II. What Are the Topics We Intend to Address at the Public Workshop?
We hope to discuss a large number of issues at the public workshop,
including, but not limited to the following:
What are the types of clinical scenarios that would make
use of medical device interoperability?
What are the issues associated with premarket and
postmarket studies for interoperable medical devices?
What tools (e.g., standards, guidances) are in place or
need to be developed to assure safety and effectiveness of
interoperable medical device systems? What issues should they address?
What are the risks associated with medical device
interoperability and ``system of systems'' composing medical devices?
What are other issues relevant to assuring the safety and
effectiveness of interoperable medical devices?
[[Page 69126]]
III. Where Can I Find Out More About This Public Workshop?
Background information on the public workshop, registration
information, the agenda, information about lodging, and other relevant
information will be posted, as it becomes available, on the Internet at
http://www.fda.gov/cdrh/meetings.html and at http://mdpnp.org/FDA_Interop_Workshop.php.
Transcripts: Transcripts of the public workshop may be requested in
writing from the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857,
approximately 15 working days after the public workshop at a cost of 10
cents per page. A transcript of the public workshop will be available
on the Internet at http://www.regulations.gov.
Dated: December 18, 2009.
Jeffrey Shuren,
Acting Director, Center for Devices and Radiological Health.
[FR Doc. E9-30871 Filed 12-29-09; 8:45 am]
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