Opportunity Information: Apply for PAR 13 232
Apply for PAR 13 232
- The Food Drug Administration in the business and commerce consumer protection health sector is offering a public funding opportunity titled "Advancing Medical Device Postmarket Surveillance Infrastructure and Epidemiologic Methodologies through Multi stakeholder Partnership (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 Jun 10, 2013 and posted on May 22, 2013.
- Applicants must submit their applications by Apr 30, 2017 This FOA has multiple receipt dates. The first application due date is July 5, 2013, by 1159 PM Eastern Time. The next application due date(s) are April 30, 2014, 2015, 2016, 2017 by 1159 PM Eastern Time.. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $1,100,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $1,100,000.00 in funding.
- Eligible applicants include: State governments Small businesses City or township governments Private institutions of higher education County governments Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Independent school districts Others (see text field entitled Additional Information on Eligibility for clarification) For profit organizations other than small businesses.
- Non domestic (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.
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
Opportunity Summary:
The FDA funding opportunity PAR 13-232, titled "Advancing Medical Device Postmarket Surveillance Infrastructure and Epidemiologic Methodologies through Multi-stakeholder Partnership (U01)," is a cooperative agreement designed to strengthen how the United States monitors medical devices after they reach the market. The central aim is to advance the National Medical Device Postmarket Surveillance System by supporting practical, sustainable collaborations among multiple stakeholders. In plain terms, the FDA is looking to fund work that helps build and maintain a long-term, partnership-based infrastructure for postmarket surveillance, rather than one-off studies that do not scale or persist.
A major focus of this opportunity is methodological innovation in epidemiology as it applies to medical devices in real-world settings. Projects are expected either to develop new epidemiologic methods or to adapt existing methods in novel ways so that device performance and patient outcomes can be understood more completely outside the controlled environment of premarket trials. This includes addressing the challenges that are especially common with devices, such as changes in device design over time, learning curves for clinicians, differences in how devices are used across settings, the need to track device-specific identifiers, and the difficulty of selecting appropriate comparison groups when randomization is not feasible. The intent is to produce approaches that yield credible, decision-ready evidence about benefits and risks as devices are used in routine care.
The FOA also emphasizes building or improving systems for data collection and analytics that enable active, prospective risk identification. Rather than relying only on passive reporting or retrospective analyses, the FDA is interested in systems that can detect safety signals earlier and support ongoing, structured evaluation. This includes efforts such as periodic and systematic updates of evidence syntheses, enhanced analytic pipelines, and visual analytics that help interpret complex patterns across large and diverse datasets. A key theme is the ability to apply sophisticated methods across multiple data sources and to make those methods usable for postmarket surveillance at scale, including near real-time or regularly refreshed monitoring when appropriate.
Another core objective is to develop methodological approaches and/or operational systems that translate postmarket information into regulatory decision-making throughout the entire device lifecycle. That means the funded work should help connect evidence generation to how regulators, manufacturers, clinicians, and health systems make decisions, from early postmarket use through updates, labeling changes, safety communications, post-approval study requirements, and potential design modifications. The FDA is signaling that it values not only statistical rigor, but also frameworks, tools, and workflows that make evidence actionable and transparent for regulatory purposes.
The opportunity further seeks to expand the availability and accessibility of high-quality data sources suitable for comprehensive postmarket evaluation. In practice, this can include improving access to, linkage among, or quality of data streams such as electronic health records, claims, device registries, unique device identifier (UDI) data, and other real-world evidence sources. The emphasis on "high quality" implies attention to completeness, standardization, validation, governance, and the ability to capture clinically meaningful outcomes and device exposure accurately enough to support reliable assessments of performance and safety.
Administratively, this funding mechanism is a U01 cooperative agreement, meaning the FDA anticipates substantial programmatic involvement during the project rather than operating purely as a hands-off funder. The opportunity was posted May 22, 2013, created June 10, 2013, and had multiple receipt dates, with the first due in late June/early July 2013 and subsequent annual deadlines through April 30, 2017. The program was archived May 30, 2017. The estimated total funding listed is $1.1 million, with an award ceiling of $1.1 million, and there is no cost sharing or matching requirement.
Eligibility is broad and includes state and local governments, tribal governments and tribal organizations, public and private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) entities), public housing authorities, independent school districts, small businesses, and other for-profit organizations beyond small businesses. Importantly, foreign institutions are eligible to apply, and foreign components of U.S. organizations are allowed, reflecting an openness to international collaboration where it supports U.S. postmarket surveillance goals. The administering agency is the Food and Drug Administration under CFDA 93.103 (FDA Research). For applicants needing help accessing the full announcement, the grants management contact listed is Lisa Ko (lisa.ko@fda.hhs.gov), and the FOA points to the NIH Guide listing for the complete announcement text.
FAQs: FDA Grant PAR 13-232 (U01) - Advancing Medical Device Postmarket Surveillance Infrastructure and Epidemiologic Methodologies through Multi-stakeholder Partnership
What is the funding opportunity PAR 13-232?
PAR 13-232 is an FDA funding opportunity for a U01 cooperative agreement titled "Advancing Medical Device Postmarket Surveillance Infrastructure and Epidemiologic Methodologies through Multi-stakeholder Partnership (U01)." It is intended to strengthen how the United States monitors medical devices after they are on the market by supporting sustainable, multi-stakeholder collaborations and practical surveillance infrastructure.
What is the main goal of this program?
The central goal is to advance the National Medical Device Postmarket Surveillance System by funding work that can help build, improve, and maintain long-term, partnership-based infrastructure for postmarket surveillance. The emphasis is on efforts that scale and persist over time, rather than one-off studies that do not translate into a durable system.
What does "postmarket surveillance" mean in this context?
Postmarket surveillance refers to monitoring and evaluating medical device performance and patient outcomes after devices are commercially available and used in routine care. This includes detecting safety signals, assessing benefits and risks in real-world settings, and generating evidence that can support ongoing evaluation throughout the device lifecycle.
What does the FDA mean by "multi-stakeholder partnership"?
The opportunity emphasizes collaborations among multiple stakeholders to support practical, sustainable postmarket surveillance. While the specific composition can vary by project, the intent is that partnerships help create infrastructure and methods that can be used broadly and maintained over time.
Is the program focused on building infrastructure, conducting research, or both?
Both. The FOA emphasizes (1) building or improving postmarket surveillance infrastructure and systems for data collection and analytics, and (2) methodological innovation in epidemiology to produce credible, decision-ready evidence about device performance and patient outcomes in real-world use.
What kinds of methodological work is the FDA looking for?
Projects are expected to develop new epidemiologic methods or adapt existing methods in novel ways for medical devices in real-world settings. The aim is to address challenges that are common with devices and improve the credibility and usefulness of evidence generated outside controlled premarket trials.
What real-world challenges specific to medical devices are highlighted in the FOA?
The FOA calls out several device-specific challenges, including device design changes over time, clinician learning curves, variation in device use across care settings, the need to track device-specific identifiers, and difficulty selecting appropriate comparison groups when randomization is not feasible.
Does the FOA prioritize real-world evidence (RWE) approaches?
Yes. The opportunity is centered on understanding device performance and patient outcomes in routine care using real-world settings and data sources, rather than relying only on premarket trial environments.
What does the FOA say about active vs. passive surveillance?
The FOA emphasizes building or improving systems that enable active, prospective risk identification, rather than relying only on passive reporting or retrospective analyses. The goal is earlier detection of safety signals and ongoing, structured evaluation.
What kinds of analytics capabilities are encouraged?
Examples mentioned include periodic and systematic updates of evidence syntheses, enhanced analytic pipelines, and visual analytics that help interpret complex patterns across large and diverse datasets. A key theme is making sophisticated methods usable at scale across multiple data sources, potentially including near real-time or regularly refreshed monitoring where appropriate.
How should funded work support regulatory decision-making?
The FOA seeks approaches and/or operational systems that translate postmarket information into regulatory decision-making across the full device lifecycle. This includes connecting evidence generation to decisions made by regulators and other stakeholders, such as labeling changes, safety communications, post-approval study requirements, and potential design modifications.
Is statistical rigor the only priority?
No. The FOA indicates value in statistical rigor as well as frameworks, tools, and workflows that make evidence actionable and transparent for regulatory purposes.
What data sources are in scope for this opportunity?
The FOA emphasizes expanding the availability and accessibility of high-quality data sources suitable for comprehensive postmarket evaluation. Examples include electronic health records, claims data, device registries, unique device identifier (UDI) data, and other real-world evidence sources.
What does the FOA mean by "high-quality" data?
Based on the description, "high quality" implies attention to data completeness, standardization, validation, governance, and the ability to capture clinically meaningful outcomes and device exposure accurately enough to support reliable assessments of performance and safety.
What is the funding mechanism?
The funding mechanism is a U01 cooperative agreement. This means the FDA anticipates substantial programmatic involvement during the project, rather than operating purely as a hands-off funder.
What does "substantial programmatic involvement" imply for applicants?
It implies that the FDA expects to be actively involved during the project in a programmatic way (consistent with a cooperative agreement), as opposed to providing funding with minimal ongoing interaction.
How much funding is available under this opportunity?
The estimated total funding listed is $1.1 million, and the award ceiling is $1.1 million.
Is there a cost sharing or matching requirement?
No. The FOA states there is no cost sharing or matching requirement.
When was this opportunity posted and what is its current status?
The opportunity was posted May 22, 2013, created June 10, 2013, and later archived on May 30, 2017. The receipt dates included the first deadline in late June/early July 2013, with subsequent annual deadlines through April 30, 2017.
Who is eligible to apply?
Eligibility is broad and includes state and local governments, tribal governments and tribal organizations, public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) entities), public housing authorities, independent school districts, small businesses, and other for-profit organizations beyond small businesses.
Are foreign institutions eligible?
Yes. Foreign institutions are eligible to apply, and foreign components of U.S. organizations are allowed.
What is the administering agency and program identifier?
The administering agency is the Food and Drug Administration (FDA). The CFDA program identifier listed is 93.103 (FDA Research).
Where can applicants find the full announcement text?
The FOA points to the NIH Guide listing for the complete announcement text.
Who is the grants management contact for help accessing the announcement?
The grants management contact listed is Lisa Ko, reachable at lisa.ko@fda.hhs.gov.
Is this opportunity intended for one-off studies?
No. The FOA specifically emphasizes building and maintaining long-term, partnership-based infrastructure for postmarket surveillance, rather than isolated studies that do not scale or persist.
Does the FOA address tracking devices using identifiers?
Yes. The FOA highlights the need to track device-specific identifiers and references UDI data as an example of an important data stream for postmarket evaluation.
Does the FOA encourage work that can operate across multiple data sources?
Yes. A key theme is the ability to apply sophisticated methods across multiple data sources and make them usable for postmarket surveillance at scale.
Browse more opportunities from the same agency: Food Drug Administration
Browse more opportunities from the same category: Business and Commerce Consumer Protection Health
Next opportunity: FY13 Safety Analysis of Electronically Controlled Pneumatic (ECP)Brake Equipment for Passenger Trains
Previous opportunity: United States Renal Data System (USRDS) Special Study Centers (U01)
USGrants.org Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for PAR 13 232
[Watch] how do funding administrators access proposals?
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Subscribe to Leads
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "PAR 13 232", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.