OpportunityTitle: Developing Innovative Methodologies and Device-Specific Infrastructure through the Medical Device Epidemiology Network: Applications for Medical Countermeasure-Associated Devices (U01)
AdditionalInformationOnEligibility: Non-doemstic (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.
Description: 1. Advance and apply innovative methodological solutions to bridge premarket and postmarket evidence of medical countermeasures (MCM)-related device safety and effectiveness, including evidence synthesis, and evaluation of medical device patient-centered outcomes across the total product life cycle (TPLC). 2. Conduct highest quality independent research to contribute to medical device regulatory decision-making for MCM-priority medical devices and radiological health. 3. Advance development, implementation, and evaluation of postmarketing surveillance systems and their application to MCM-priority medical device regulatory science. 4. Promote communication with stakeholders and educational outreach of innovative MCM medical device surveillance and scientific strategies
GrantorContactEmailDescription: lisa.ko@fda.hhs.gov
GrantorContactText: Lisa Ko &lt;br/&gt;Grants Management Specialist