Enhancing Post-Market Surveillance Through Developing Registries for Medical Device Epidemiology (U01)

| Global Health Funding



United States Department of Health and Human Services (HHS)

Food and Drug Administration (FDA)

Center for Devices and Radiological Health (CDRH)


Upper  $750,000USD

FDA/CDRH intends to commit up to the following amounts:
Fiscal Year 2017: $300,000

It is anticipated that up to 2 awards will be made per is anticipated that up to 2 awards will be made per Fiscal Year, not to exceed $150,000 in total costs (direct plus indirect) per award, per year.

Typically, this will be one year. Applicants may propose a multi-year project period, up to 5 years.


The purposes of this PAR are as follows:
1. To address identified gaps in the current post market surveillance system by

developing new methodologies for registry data collection and linkage, or by adapting known methodologies to medical devices.
2. To develop novel methodology that allows for use of the registry data collection infrastructure to serve multiple purposes including postmarket surveillance, device tracking through Unique Device Identifiers (UDI), prospective embedded studies, quality improvement, and other uses.
3. To develop registries and consortia in key medical device areas to implement new registry methodologies that strategically broaden the scope of the U.S. and international postmarket surveillance system.

Upcoming Deadlines

13 May 2017 (Confirmed) – Application (Sponsor deadline – required)

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