This funding opportunity is focused on supporting translational activities and clinical studies to advance the development of therapeutic, and diagnostic devices for disorders that affect the nervous or neuromuscular systems. Activities supported by this FOA include implementation of clinical prototype devices, non-clinical safety and effectiveness testing, design verification and validation activities. Additional activities include obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, as well as support for a subsequent clinical feasibility study. The clinical study is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use.
Projects must focus on a disorder that falls within the mission of participating NIH Blueprint Institutes and Centers. It is expected that devices within the scope of this program either:
- are very close to the ‘final system’ and manufactured using very close to the same manufacturing process as the device to be marketed or studied in a larger clinical trial following the completion of this project; or
- have received Pre-Submission feedback from the FDA (see https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program and https://www.fda.gov/training-and-continuing-education/cdrh-learn, Q-submissions for additional resources);
- require early feasibility clinical data to inform the final device design or manufacturing processes.
The NIH has encouraged that those interested in applying to this funding opportunity should email a draft of their specific aims page toBlueprint-MedTech@nih.gov
Due Dates for new submissions are June 20, 2022 and October 18, 2022.
URLs for more information:
PAR-21-315 Blueprint MedTech Translator (UG3/UH3 – Clinical Trial Optional)
PAR-21-282 Blueprint MedTech: Small Business Translator (U44 – Clinical Trial Optional)
Filed Under: Funding Opportunities