Food and Drug Administration

Description

1) To support implementation of the National Medical Device Postmarket Surveillance System through sustainable multi-stakeholder partnership 2) To develop new epidemiologic methodologies or to apply existing methodologies in new ways to provide a comprehensive understanding of medical device performance and clinical outcomes associated with device use in real-world use settings;3) To develop new systems of data collection and/or analysis to permit prospective active medical device postmarket risk identification , periodic systematic updates of comprehensive evidence syntheses, visual analytics, and other efforts to broadly apply complex methodology to diverse data sources that facilitates postmarket surveillance;4) To develop methodological approaches and/or systems that facilitate the use of postmarket information for regulatory decision making throughout the entire device lifecycle ; and 5) To support the development of and access to high quality data sources that can be used in comprehensive postmarket evaluation of medical device performance and associated outcomes.

Who can apply

• State governments
• County governments
• City or township governments
• Special district governments
• Independent school districts
• Public and State controlled institutions of higher education
• Native American tribal governments (Federally recognized)
• Public housing authorities / Indian housing authorities
• Native American tribal organizations (other than Federally recognized)
• Nonprofits with 501(c)(3) status (other than higher education)
• Nonprofits without 501(c)(3) status (other than higher education)
• Private institutions of higher education
• For-profit organizations other than small businesses
• Small businesses
• Others

Contact

Lisa Ko <br/>Grants Management Officer
Lisa.Ko@fda.hhs.gov