Developing Innovative Methodologies and Device-Specific Infrastructure through the Medical Device Epidemiology Network: Applications for Medical Countermeasure-Associated Devices (U01)

Food and Drug Administration

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

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 Specialist
lisa.ko@fda.hhs.gov