Opportunity Information: Apply for PAR 14 295
Apply for PAR 14 295
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS CREATE Devices Translational and Clinical Studies on the Path to 510(k) (UH2/UH3)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders.
- This funding opportunity was created on Jul 28, 2014 and posted on Jul 28, 2014.
- Applicants must submit their applications by May 7, 2017. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: State governments Private institutions of higher education County governments Independent school districts Nonprofits that do not have 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 Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Public housing authorities/Indian housing authorities For profit organizations other than small businesses Native American tribal governments (Federally recognized) Others (see text field entitled Additional Information on Eligibility for clarification) City or township governments Special district governments.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
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Opportunity Summary:
The NINDS CREATE Devices Translational and Clinical Studies on the Path to 510(k) (UH2/UH3) opportunity (Funding Opportunity Number PAR 14 295) is a National Institutes of Health grant program designed to move promising therapeutic neurological devices out of early development and into the specific translational and clinical steps needed for U.S. FDA clearance. In practical terms, the FOA targets the gap between having a credible device concept or prototype and being able to generate the safety, performance, and clinical evidence needed to file a 510(k) or 510(k) De Novo submission. The core focus is on therapeutic devices intended to treat neurological disorders, and the funded work is expected to be directly aligned with a realistic regulatory pathway, rather than exploratory research for its own sake.
A central feature of this FOA is that it uses a cooperative agreement mechanism (UH2/UH3), which typically means NIH staff will have substantial scientific and programmatic involvement compared with a standard investigator-initiated grant. The structure is meant to support a milestone-driven progression from preparatory translational tasks into a defined clinical study. The program specifically supports the regulatory setup needed to run a clinical study, including either submission of an Investigational Device Exemption (IDE) to FDA or obtaining IRB approval for a Non Significant Risk (NSR) study, followed by execution of the clinical study itself. The expectation is that the funded project is not just "preparing for clinical work," but actually reaches the point of conducting a small clinical study that meaningfully advances the device toward clearance.
The FOA makes clear what success is supposed to look like at the end of the award. Upon completion of the supported clinical study, the immediate next step should be either a 510(k)/510(k) De Novo submission or a larger clinical trial that is explicitly designed to lead directly to a 510(k)/510(k) De Novo submission. That language signals that applicants need to present a credible, regulatorily grounded plan for how the clinical data will be used, what the likely predicate or De Novo strategy is, and how the proposed study fits into that plan. The intent is to fund projects where the funded activities are the last major steps before a clearance-focused submission, or the final de-risking step before a pivotal, clearance-enabling trial.
In terms of the work that can be supported, the FOA includes a fairly complete set of device-translation activities. It supports implementation of clinical prototype devices, meaning the device should be mature enough to be built and used in a clinical setting with appropriate controls and documentation. It also supports preclinical safety and efficacy testing, which can include bench testing and animal testing as needed to justify human use and satisfy regulatory expectations. The FOA also explicitly supports design verification and validation activities, which are the kinds of engineering and quality-system aligned tests used to demonstrate that the device meets its design requirements and that the final design is suitable for its intended use. On top of that, it supports pursuit of regulatory approval for the clinical study itself (IDE or NSR determination/IRB pathway) and then the small clinical study that follows.
Eligibility for this program is broad across U.S.-based organizations and includes state, county, city/township, and special district governments; public and private institutions of higher education; nonprofits (including 501(c)(3) and certain non-501(c)(3) organizations); small businesses; and for-profit organizations other than small businesses. It also includes specific institution types and community-focused entities such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based and community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. At the same time, the FOA states that non-U.S. entities are not eligible to apply, non-U.S. components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed, which effectively confines the work and applicant organization footprint to the United States.
Administratively, the opportunity falls under NIH’s health research mission and is associated with CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). The program does not require cost sharing or matching. The FOA was posted and created on July 28, 2014, and the original and final closing date listed in the source information is May 7, 2017, with an archive date of June 7, 2017, indicating this particular announcement is no longer active but remains useful as a reference for the program’s design and expectations. For the original announcement text and details, the source link is provided at http://grants.nih.gov/grants/guide/pa-files/PAR-14-295.html, and general access or linking issues were directed to the NIH Office of Extramural Research webmaster contact in the notice.
Stepping back, the main takeaway is that PAR 14 295 was built for teams that are beyond discovery and are ready to do the disciplined engineering, preclinical package development, regulatory preparation, and early clinical evaluation needed to credibly reach a 510(k) or De Novo submission decision point. It is fundamentally a translation-and-clinical-readiness program for neurological therapeutic devices, with an emphasis on regulatory alignment, prototype readiness, and generating human data that fits into a near-term FDA clearance strategy.
FAQs: NINDS CREATE Devices Translational and Clinical Studies on the Path to 510(k) (UH2/UH3) - PAR-14-295
What is PAR-14-295 (NINDS CREATE Devices) designed to fund?
PAR-14-295 is an NIH (NINDS) cooperative agreement program (UH2/UH3) intended to move promising therapeutic neurological devices from credible concept/prototype into the translational and clinical steps needed to support a U.S. FDA 510(k) or 510(k) De Novo pathway. The emphasis is on generating the safety, performance, and clinical evidence required for a clearance-focused regulatory strategy, not exploratory research.
What types of devices are the focus of this opportunity?
The focus is on therapeutic devices intended to treat neurological disorders. Projects are expected to be aligned with a realistic U.S. FDA clearance pathway toward 510(k) or 510(k) De Novo.
What is the biggest gap this FOA is trying to address?
It targets the gap between having a credible device concept or prototype and having the safety, performance, and clinical evidence needed to file a 510(k) or 510(k) De Novo submission. In other words, it supports the work that turns a promising device into a clearance-ready development package.
What does the UH2/UH3 mechanism mean in practice?
The program uses a cooperative agreement mechanism (UH2/UH3), which generally means NIH staff are expected to have substantial scientific and programmatic involvement compared to a standard investigator-initiated grant. The structure is milestone-driven and intended to support progression from preparatory translational activities into a defined clinical study.
Does the program support actual clinical studies, or only preparation?
The expectation is that the project reaches the point of conducting a small clinical study that meaningfully advances the device toward clearance. The FOA is not limited to preparation; it supports regulatory setup for the clinical study and execution of the study itself.
What regulatory steps for the clinical study are supported?
The FOA supports the regulatory setup needed to run a clinical study, including either submission of an Investigational Device Exemption (IDE) to FDA or obtaining IRB approval for a Non Significant Risk (NSR) study, followed by conducting the clinical study.
What kinds of development and testing activities can be supported?
The FOA supports a broad set of device-translation activities, including implementation of clinical prototype devices, preclinical safety and efficacy testing (including bench and animal testing as needed), design verification and validation activities, regulatory preparation for the clinical study (IDE or NSR/IRB pathway), and the small clinical study that follows.
What does "clinical prototype device" imply for readiness?
It implies the device should be mature enough to be built and used in a clinical setting with appropriate controls and documentation, consistent with the program's translational and regulatory alignment goals.
What are design verification and validation in the context of this FOA?
They are engineering and quality-system aligned tests intended to demonstrate the device meets its design requirements (verification) and that the final design is suitable for its intended use (validation). The FOA explicitly supports these activities as part of the path toward clearance-focused evidence generation.
What does success look like by the end of the award?
Upon completion of the supported clinical study, the immediate next step should be either a 510(k)/510(k) De Novo submission or a larger clinical trial explicitly designed to lead directly to a 510(k)/510(k) De Novo submission. Applicants are expected to present a credible plan for how clinical data will be used within a realistic FDA clearance strategy (predicate or De Novo approach).
Is this FOA meant for exploratory research projects?
No. The FOA emphasizes work directly aligned with a realistic regulatory pathway toward FDA clearance, rather than exploratory research for its own sake.
Who is eligible to apply (in general terms)?
Eligibility is broad across U.S.-based organizations, including state, county, city/township, and special district governments; public and private institutions of higher education; nonprofits (including 501(c)(3) and certain non-501(c)(3) organizations); small businesses; and for-profit organizations other than small businesses.
Are minority-serving and community-focused institutions included in eligibility?
Yes. The FOA includes eligibility for organizations such as HBCUs, Hispanic-serving Institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, as well as faith-based and community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.
Are non-U.S. organizations or foreign components allowed?
No. The FOA states that non-U.S. entities are not eligible to apply, non-U.S. components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed. This effectively confines the applicant organization footprint and work to the United States.
Is cost sharing or matching required?
No. The program does not require cost sharing or matching.
What agency and program area is this opportunity associated with?
It is part of NIH's health research mission under NINDS and is associated with CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders).
Is this funding opportunity still active?
No. The source information indicates the FOA was posted/created on July 28, 2014, with an original and final closing date of May 7, 2017, and an archive date of June 7, 2017. That indicates this specific announcement is no longer active, though it can still serve as a reference for program design and expectations.
Where can the original announcement be found?
The original FOA text and details are available at http://grants.nih.gov/grants/guide/pa-files/PAR-14-295.html.
What should teams be ready to do before applying (based on the FOA's intent)?
The program is built for teams that are beyond discovery and ready for disciplined engineering, preclinical package development, regulatory preparation, and early clinical evaluation that credibly supports a near-term FDA 510(k) or De Novo submission decision point.
Does the FOA indicate what kind of clinical study is expected?
It indicates a small clinical study is expected, and it should meaningfully advance the device toward clearance. The clinical work is positioned as a key step immediately preceding a 510(k)/De Novo submission or preceding a larger, clearance-enabling trial.
What is the main practical takeaway of PAR-14-295?
It is a translation-and-clinical-readiness program for therapeutic neurological devices, emphasizing prototype readiness, verification/validation, preclinical support as needed, regulatory alignment (IDE or NSR/IRB), and generating human data that fits into a near-term FDA clearance strategy.
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Applicants also applied for:
Applicants who have applied for this opportunity (PAR 14 295) also looked into and applied for these:
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|---|
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| NINDS CREATE Devices Translational and Clinical Studies to Inform Final Device Design (UH2/UH3) Apply for PAR 14 297 Funding Number: PAR 14 297 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
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