Translational Devices

Translational Devices

General Information

Chart displays the Translational Devices program provides support for the development, optimization, translation, and first-in-human testing of therapeutic and diagnostic devices for disorders that affect the nervous or neuromuscular systems. The program consists of funding opportunities for investigator initiated projects at the NINDS (RFA-NS-18-011 / RFA-NS-18-012), as well as in the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) (RFA-NS-18-021 / RFA-NS-18-022 / RFA-NS-18-023)

The Translational Devices program provides support for the development, optimization, translation, and first-in-human testing of therapeutic and diagnostic devices for disorders that affect the nervous or neuromuscular systems. The program consists of funding opportunities for investigator initiated projects at the NINDS (RFA-NS-18-011 / RFA-NS-18-012) and  the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) (RFA-NS-18-021 / RFA-NS-18-022 / RFA-NS-18-023).

The next two receipt dates are June 22, 2020 and October 21, 2020.

In addition to the above funding announcements, the Translational Device Program is currently supporting projects from the follwoing Funding Announcements, but there are no future receipt dates currently available:

Helping to End Addiction Long-Term (HEAL) 

Program Snap Shots

NINDS Translational Neural Devices

  • CT Required
  • Invasive or noninvasive
  • CNS or PNS
  • Diagnostic or Therapeutic
  • Within NINDS Mission
  • Budgets should rarely exceed:
    • UG3: $1MDC/yr
    • UH3: $1.5M DC/yr
    • U44 Phase I: $1M TC/yr
    • U44 Phase II: $1.5M TC/yr
       

BRAIN Initiative Next Generation Devices

  • CT Required
  • Invastive only
  • CNS only
  • Diagnostic or Therapeutic
  • Within mission of a BRAIN IC
  • Budgets:
    • UG3/UH3: No budget limit
    • U44 Phase I: $1.5M TC/yr
    • U44 Phase II: $1.5M TC/yr
       

  • All funding opportunities for investigator-initiated projects use cooperative agreement mechanisms and are milestone-driven. This type of mechanism involves NIH program staff's participation in developing the project milestones and plans, monitoring the research progress, and making go/no-go decisions.
  • For projects that have completed all non-clinical testing necessary to obtain an IDE or obtained NSR designation from a local IRB, straight to clinical options (UH3 and SBIR U44 Phase II) are available in the BRAIN Initiative.
  • Phased cooperative agreement mechanisms (UG3/UH3 and SBIR U44 Fast-Track) support pre-clinical/translational device activities, including translational bench and animal studies, and are expected to lead to an Investigation Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to support a small clinical trial, or a Non-Significant Risk (NSR) designation from an Institutional Review Board (IRB) in the first phase. The subsequent phase supports the small clinical study or trial to collect safety and effectiveness data required to support a marketing application, or to inform final device design.

 

All Applicants are strongly encouraged to contact translational device staff at least two months prior to the receipt date.