Opportunity Information: Apply for RFA FD 12 028
Apply for RFA FD 12 028
- The Food Drug Administration in the health information and statistics science and technology and other research and development sector is offering a public funding opportunity titled "Enhancing post market surveillance through developing registries for medical device epidemiology (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103 Food and Drug AdministrationResearch.
- This funding opportunity was created on May 15, 2012 and posted on May 15, 2012.
- Applicants must submit their applications by Jun 25, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $250,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $125,000.00 in funding.
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: Public and State controlled institutions of higher education Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than 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 (FDC Act). Section 566(b) of the FDC 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).
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Opportunity Summary:
The Food and Drug Administration (FDA) funding opportunity "Enhancing post market surveillance through developing registries for medical device epidemiology (U01)" (Funding Opportunity Number RFA-FD-12-028) was a discretionary, cooperative agreement program designed to strengthen how medical devices are monitored after they enter real-world clinical use. The central idea is that better, more modern registry infrastructure can fill persistent weaknesses in postmarket surveillance by producing higher-quality evidence on device performance, safety, and effectiveness across diverse patient populations and care settings. Rather than focusing on a single narrow research question, the opportunity emphasizes building or improving systems (registries and consortia) that can continuously generate useful epidemiologic data about devices over time.
The announcement lays out three main goals. First, it aims to support the development of registries and consortia in key medical device areas, with an emphasis on implementing new registry methodologies that can strategically broaden the scope of postmarket surveillance in the United States and internationally. In practical terms, this means building collaborative networks and data platforms in clinical areas where device use is common or where surveillance gaps are most consequential, and doing so in a way that can scale beyond one institution or one dataset. Second, the opportunity seeks to directly address known shortcomings in the existing surveillance system by developing new methods for registry data collection and linkage, or by adapting established methods so they work well for medical devices. That includes improving how device exposure is captured, how outcomes are defined and validated, and how registry data can be linked to other sources (for example, claims, electronic health records, or other registries) to enable more complete follow-up and stronger analyses. Third, the FDA is looking for novel methodology that allows the same registry infrastructure to serve multiple purposes at once, not just passive surveillance. The registry systems envisioned here should be usable for postmarket safety monitoring, device tracking through Unique Device Identifiers (UDIs), prospective embedded studies (including pragmatic or registry-based study designs), quality improvement initiatives, and other related uses that make the infrastructure more valuable and sustainable.
From a funding and administrative standpoint, this was a cooperative agreement (U01), which generally signals substantial FDA involvement during the project period compared with a traditional grant. The program expected to make two awards, with an estimated total funding level of $250,000 and an award ceiling of $125,000 per award (no stated award floor). There was no cost sharing or matching requirement. The funding was supported through FDA "Critical Path" funds authorized under Section 566 of the Federal Food, Drug, and Cosmetic Act, which defines eligible entities as institutions of higher education (or consortia of such institutions) and 501(c)(3) nonprofit organizations that are tax-exempt under section 501(a). Reflecting that statutory basis, eligible applicants included public and state-controlled institutions of higher education, private institutions of higher education, and nonprofit 501(c)(3) organizations other than institutions of higher education.
The opportunity was posted on May 15, 2012, with an original and final closing date of June 25, 2012, and an archive date of July 25, 2012. The program is associated with CFDA number 93.103 (Food and Drug Administration Research) and falls under health information and statistics as well as science and technology/research and development. The full announcement was hosted through the NIH Guide for Grants and Contracts, and applicants needing help accessing it were directed to contact the FDA grants management specialist Lisa Ko (lisa.ko@fda.hhs.gov).
Frequently Asked Questions (FAQs)
1. What is the title and funding opportunity number for this grant?
The opportunity is titled "Enhancing post market surveillance through developing registries for medical device epidemiology (U01)" and the Funding Opportunity Number is RFA-FD-12-028.
2. Which federal agency offered this funding opportunity?
This opportunity was offered by the U.S. Food and Drug Administration (FDA).
3. What type of funding mechanism is this award?
This is a cooperative agreement under the U01 activity code, which generally indicates substantial involvement by FDA during the project period compared with a traditional grant.
4. What is the main purpose of this funding opportunity?
The main purpose is to strengthen postmarket surveillance of medical devices by developing or improving registry infrastructure and related methods so higher-quality evidence can be produced on device performance, safety, and effectiveness in real-world clinical use across diverse patient populations and care settings.
5. Does this opportunity focus on answering a single research question?
No. Rather than focusing on one narrow research question, it emphasizes building or improving systems (registries and consortia) that can continuously generate useful epidemiologic data about medical devices over time.
6. What are the three main goals described in the announcement?
The announcement describes three main goals: (1) support development of registries and consortia in key medical device areas, emphasizing new registry methodologies that broaden postmarket surveillance in the U.S. and internationally; (2) address shortcomings in existing surveillance by developing or adapting methods for registry data collection and linkage (including improved capture of device exposure, outcome definition/validation, and linkage to other data sources); and (3) develop novel methodology so the same registry infrastructure can serve multiple purposes, not only passive surveillance.
7. What kinds of activities or deliverables does the FDA want supported?
Based on the description, the FDA wanted work that builds or improves registry and consortium infrastructure, advances methods for collecting and linking registry data, improves capture of device exposure and outcomes, and enables registry systems to support multiple uses such as safety monitoring, device tracking, embedded studies, and quality improvement initiatives.
8. What surveillance weaknesses is this opportunity trying to address?
It targets persistent weaknesses in postmarket surveillance by promoting modern registry infrastructure that can produce higher-quality evidence, including better capture of device exposure, clearer and validated outcome definitions, and improved follow-up through linkage with other data sources.
9. What does "postmarket surveillance" mean in the context of this opportunity?
In this context, postmarket surveillance refers to monitoring medical devices after they have entered real-world clinical use, with the goal of generating evidence on performance, safety, and effectiveness over time.
10. What kinds of data linkages are mentioned as important?
The announcement notes the importance of linking registry data to other sources to enable more complete follow-up and stronger analyses. Examples provided include claims data, electronic health records (EHRs), and other registries.
11. How does the opportunity describe capturing device exposure?
It highlights improving how device exposure is captured as a key methodological need, alongside better outcome definition/validation and data linkage for follow-up.
12. Is international scope mentioned, or is this limited to the United States?
International scope is explicitly mentioned. One goal is to implement new registry methodologies that can strategically broaden the scope of postmarket surveillance in the United States and internationally.
13. What is meant by making registry infrastructure "multi-purpose"?
The opportunity emphasizes that registry infrastructure should support multiple purposes beyond passive surveillance, including postmarket safety monitoring, device tracking through Unique Device Identifiers (UDIs), prospective embedded studies (including pragmatic or registry-based designs), quality improvement initiatives, and other related uses that increase value and sustainability.
14. Are Unique Device Identifiers (UDIs) specifically mentioned?
Yes. The announcement includes device tracking through Unique Device Identifiers (UDIs) as one of the purposes the registry infrastructure should be able to support.
15. How many awards were expected under this funding opportunity?
The program expected to make two awards.
16. What was the estimated total funding amount and the maximum per award?
The estimated total funding level was $250,000, and the award ceiling was $125,000 per award. No award floor was stated.
17. Was cost sharing or matching required?
No. The opportunity states there was no cost sharing or matching requirement.
18. What is the statutory or funding source noted for this program?
The funding was supported through FDA "Critical Path" funds authorized under Section 566 of the Federal Food, Drug, and Cosmetic Act.
19. Who was eligible to apply?
Eligible entities (reflecting the Section 566 basis described) included institutions of higher education (or consortia of such institutions) and 501(c)(3) nonprofit organizations that are tax-exempt under section 501(a). The eligible applicant types listed include public and state-controlled institutions of higher education, private institutions of higher education, and nonprofit 501(c)(3) organizations other than institutions of higher education.
20. Are consortia allowed as applicants?
Yes. The description notes eligibility includes institutions of higher education or consortia of such institutions.
21. When was the opportunity posted and what were the closing dates?
It was posted on May 15, 2012. The original and final closing date was June 25, 2012. The archive date was July 25, 2012.
22. What CFDA number is associated with this program?
The opportunity is associated with CFDA 93.103, titled Food and Drug Administration Research.
23. What subject areas does the opportunity fall under?
It falls under health information and statistics as well as science and technology/research and development.
24. Where was the full announcement hosted?
The full announcement was hosted through the NIH Guide for Grants and Contracts.
25. Who should applicants contact for help accessing the announcement?
Applicants needing help accessing the announcement were directed to contact the FDA grants management specialist Lisa Ko at lisa.ko@fda.hhs.gov.
26. What is the overarching theme of the work encouraged by the FDA in this opportunity?
The overarching theme is creating scalable, collaborative registry and consortium infrastructure and methods that modernize medical device postmarket surveillance, improve data quality and linkage, and allow the same platform to support surveillance, tracking, embedded studies, and quality improvement over time.
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