Medical Innovation Exchange

FDA Seeks Industry Collaboration on Medical Device Active Surveillance System



The FDA is seeking input from organizations interested in collaborating with the agency on the development and execution of the medical device active surveillance system. “Once realized, such a system will optimize data collection, quality, completeness, and analysis within a comprehensive framework to assess potential and ongoing safety signals in a timely manner,” said the FDA in its call for sources.

Businesses of all sizes on GSA MAS Schedule 54151HEAL Health Information Technology Services with the capabilities to provide the services stated may submit a response. Businesses that do not have a contract on this schedule or any GSA schedule may submit a response as well, and small businesses are encouraged to submit a response. Interested parties must respond by March 20, 2023, at 10:00am EST.

The FDA notes that it is issuing this “source sought” notice as a means of conducting market research, pursuant to FAR Part 10 Market Research, to identify potential parties from the marketplace capable of providing professional services for the Center for Devices and Radiological Health’s (CDRH) requirement for Medical Device Active Surveillance System. The information being sought is purely voluntary and for planning purposes only.

Those interested in joining the collaboration can find more information here.

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