Conference Dates: Jan 25-27, 2010
Silver Spring, MD[edit Location]
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) will hold a public workshop entitled ‘‘Medical Device Interoperability: achieving safety and effectiveness.’’ 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.
We plan to discuss a large number of issues at the workshop, including, but not limited to:
* 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 organizations are in place to assure safety and effectiveness of interoperable medical device systems and what are their roles?
* What are the risks associated with medical device interoperability and “systems of systems” composed of medical devices?
* Any other issues relevant to assuring the safety and effectiveness of interoperable medical devices.
[edit description]Click here to register.[edit ]
Industries[edit]
Fee: $400[edit ]