Advancing Medical Device Postmarket Surveillance Infrastructure and Epidemiologic Methodologies through Multi-stakeholder Partnership (U01)

The summary for the Advancing Medical Device Postmarket Surveillance Infrastructure and Epidemiologic Methodologies through Multi-stakeholder Partnership (U01) grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Food and Drug Administration, which is the U.S. government agency offering this grant.
Advancing Medical Device Postmarket Surveillance Infrastructure and Epidemiologic Methodologies through Multi-stakeholder Partnership (U01): 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.
Federal Grant Title: Advancing Medical Device Postmarket Surveillance Infrastructure and Epidemiologic Methodologies through Multi-stakeholder Partnership (U01)
Federal Agency Name: Food and Drug Administration
Grant Categories: Business and Commerce Consumer Protection Health
Type of Opportunity: Discretionary
Funding Opportunity Number: PAR-13-232
Type of Funding: Cooperative Agreement
CFDA Numbers: 93.103
CFDA Descriptions: Food and Drug Administration_Research
Current Application Deadline: Apr 30, 2017
Original Application Deadline: Apr 30, 2017
Posted Date: May 22, 2013
Creation Date: Jun 10, 2013
Archive Date: May 30, 2017
Total Program Funding: $1,100,000
Maximum Federal Grant Award: $1,100,000
Minimum Federal Grant Award:
Expected Number of Awards:
Cost Sharing or Matching: No
Applicants Eligible for this Grant
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 tribal governments) - Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education - Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education - Private institutions of higher education - For profit organizations other than small businesses - Small businesses - Others (see text field entitled "Additional Information on Eligibility" for clarification)
Additional Information on Eligibility
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the HHS Grants Policy Statement, are allowed.
Grant Announcement Contact
Lisa Ko Grants Management Specialist

lisa.ko@fda.hhs.gov [lisa.ko@fda.hhs.gov]
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