This program seeks to encourage the translation of research discoveries into new treatments for neurological disorders and stroke that fall under the National Institute of Neurological Disorders and Stroke (NINDS) mission.
This program will utilize a UH2/UH3 cooperative agreement mechanism to support pre-clinical testing to enable an Investigational Device Exemption (IDE) submission or IRB approval for a Non-Significant Risk (NSR) study and the subsequent clinical study. This program supports pre-clinical and small clinical studies where the immediate next steps upon completion will be a 510(k)/510(k) De Novo submission or a larger clinical trial that will lead directly to a 510(k)/510(k) De Novo submission. It is expected that changes to the system design informed by the Early Feasibility Study will be minor and not require additional animal testing. Activities that can be supported in this program include implementation of clinical prototype devices, design verification and validation activities, demonstration of preclinical safety and efficacy, pursuit of U.S. regulatory approval for clinical study, and small clinical studies.
Projects must focus on a single disorder that falls within the mission of NINDS. Devices within the scope of this program are expected to be very close to the 'final system' and manufactured using very close to the same manufacturing process for any subsequent clinical studies and eventual market manufacture. If a subsequent larger clinical study is required for market approval, it is expected that any changes to the manufacturing process or the final system design informed by this small clinical study will be minor, and will not require additional pre-clinical data or clinical data prior to conducting the larger clinical study.
For entry to the program, projects should have:
- Comprehensive Supporting Data: Ideally, preliminary proof-of-concept data would be obtained using an in vivo model representative of the intended patient population.
- A compelling case to for a successful IDE submission by the end of the UH2 or IRB approval for a Non-Significant Risk (NSR) study at the end of the UH2.
- Overall device development plan, including when contact with the appropriate regulatory bodies is planned, clinical considerations, and a needs assessment.
- Identified one or more clinically meaningful device outcome measures based on input from both clinicians and patients
- Non-binding FDA Pre-Submission (formerly pre-IDE) feedback clearly denoting that the proposed pre-clinical testing plan is sufficient to support a successful FDA submission for an IDE by the end of Phase I. For Non-Significant Risk (NSR) studies, preliminary communications (e.g. letter or other documentation) with the IRB indicating what pre-clinical testing will be necessary to support the NSR clinical study is sufficient.
Examples of studies that can be proposed during the UH2 phase include, but are not limited to:
- Non-GLP (Good Laboratory Practice) animal studies to develop surgical techniques relevant to the device, define relevant therapeutic parameters, and refine device design in preparation for subsequent GLP testing for regulatory approval
- In vitro and animal testing to meet FDA Recognized ISO/ASTM Standards
- Activities to become GMP (Good Manufacturing Practice) compliant
- Activities to bring the development process under Design and Quality Systems Control
- Device, software, and firmware design verification and validation activities
- Regulatory affairs
- GLP compliant large animal model safety and/or testing of an implanted device
- IDE submission
The UH3 will support a small clinical study that will lead to either a 510(k)/510(k) De Novo submission or a larger clinical trial leading directly to a 510(k)/510(k) De Novo submission. It should be noted that clinical studies are only supported for projects where the preclinical activities are conducted under this program.