OpportunityTitle: Enhancing post-market surveillance through developing registries for medical device epidemiology (U01)
AdditionalInformationOnEligibility: Awards made under this announcement will be supported using Critical Path funds as described in Section 566 of the Federal Food Drug and Cosmetic Act (FD&amp;C Act).  Section 566(b) of the FD&amp;C Act defines eligible entities as (A) an institution of higher education (as such term is defined in section 101 of the Higher Education Act of 1965 [20 USC &#167; 1001]) or a consortium of such institutions; or (B) an organization described in section 501(c)(3) of the Internal Revenue Code of 1986 [26 USC &#167; 501(c)(3)] and exempt from tax under section 501(a) of such Code [26 USC &#167; 501(a)].
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.
GrantorContactEmailDescription: lisa.ko@fda.hhs.gov
GrantorContactText: Lisa Ko &lt;br/&gt;Grants Management Specialist