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Recently, the U.S. Food and Drug Administration (FDA) announced a solicitation of interest (Sources Sought) for organizations interested in collaborating with the FDA on the development and execution of a medical device active surveillance system that have the appropriate expertise to design, develop, and run such a system. Active surveillance utilizes extant electronic health data to assess the safety of medical products. It does not require collection of new data from patients or clinicians, nor does it require that separate safety reports be generated and sent to the monitoring entity.
The FDA is committed to development and implementation of an active surveillance system of electronic health data to better understand the safety of medical devices as used within clinical practice. 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.
Facts about the Sources Sought notice FDA-SS-75F40123Q00084:
- 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.
- Small businesses are encouraged to submit a response.
- Response due date and time: 10:00 AM EST on March 20, 2023
Questions?
If you have questions, contact Michelle Dacanay by emailing michelle.dacanay@fda.hhs.gov.
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