E9-30871. Medical Device Interoperability; Public Workshop

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop.

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, [e-mail]; 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, [e-mail].

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 ([e-mail]) 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?

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.