
[Federal Register: December 30, 2009 (Volume 74, Number 249)]
[Notices]               
[Page 69125-69126]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30de09-89]                         

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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, 
sandy.weininger@fda.hhs.gov; 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, 
john.murray@fda.hhs.gov.
    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 
(Susana.Rosales@fda.hhs.gov) 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]

BILLING CODE 4160-01-S
