Enhancing post-market surveillance through developing registries for medical device epidemiology (U01)

Post Date

May 15th 2012

Application Due Date

June 25th 2012

Funding Opportunity Number

RFA-FD-12-028

CFDA Number(s)

93.103

Funding Instrument Type(s)

Cooperative Agreement

Funding Activity Categories

Health
Information and Statistics
Science and Technology and other Research and Development

Number of Awards

2

Eligibility Categories

Public and State Controlled Institutions of Higher Education
Non-Profits With 501 (c) (3) Status With The IRS (Except Higher Education Institutions)
Private Institutions of Higher Education

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&C Act). Section 566(b) of the FD&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 _ 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 _ 501(c)(3)] and exempt from tax under section 501(a) of such Code [26 USC _ 501(a)].

Funding

• Estimated Total Funding:

  $250000

• Award Range:

  $0 - $125000

Grant 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.

Contact Information

• Agency

  Department of Health and Human Services

• Office:

  Food and Drug Administration

• Agency Contact:

  Lisa Ko
  Grants Management Specialist

• Agency Mailing Address:

  lisa.ko@fda.hhs.gov

• Agency Email Address:

  lisa.ko@fda.hhs.gov

• More Information:

  Full Announcement RFA-FD-12-028 on NIH Guide for Grants and Contracts