Food and Drug Administration

Description

(1) To develop registries and consortia in key medical device areas to implement new registry methodologies that strategically broaden the scope of the US and international postmarket surveillance system, and (2) To address identified gaps in the current postmarket surveillance system by developing new methodologies for registry data collection and linkage, or by adapting known methodologies to medical devices, and (3) 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.

Who can apply

• Public and State controlled institutions of higher education
• Nonprofits with 501(c)(3) status (other than higher education)
• Private institutions of higher education

Contact

Lisa Ko <br/>Grants Management Specialist
lisa.ko@fda.hhs.gov