This program supports non-clinical testing and clinical studies to answer key questions about the function or final design of a device. This final device design may require most, if not all, of the non-clinical testing on the path to more advanced clinical trials and market approval. The clinical study is expected to provide information that cannot be practically obtained through additional nonclinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use, yet is critical to enable next-generation diagnostic or therapeutic devices. Activities that can be supported in this program include implementation of clinical prototype devices, design verification and validation activities, demonstration of non-clinical safety and efficacy, pursuit of U.S. regulatory approval for clinical study, and a single small clinical study. As applicants must have comprehensive supporting data, including proof-of-concept demonstration with a near final prototype in a relevant animal model prior to entry, innovation will in part be judged on presenting a credible path towards an IDE or an NSR clinical study.
All projects will have two phases, UG3 and UH3. The initial UG3 phase will support nonclinical testing to support the filing of an IDE for an SR study or to obtain IRB approval for an NSR clinical study. All projects will start at the UG3 phase, and the length of UG3 phase will depend on the maturity of the project at entry. Only those UG3 projects that have met specific criteria (see below) will transition to the subsequent UH3 phase after NIH administrative review. The UH3 phase will support a small clinical study. Projects for which only a clinical phase is proposed should be submitted under RFA-NS-16-010, which utilizes the UH3 activity code.
For entry to the program, projects should have:
- Comprehensive Supporting Data: Proof-of-concept data of device function are required using a prototype device equivalent to the final device design anticipated for clinical testing, ideally obtained using an in vivo model representative of the intended patient population;
- A compelling case for a successful IDE submission to support the clinical component, or IRB approval for an NSR study, within the period of the award;
- Overall device development plan, including timeline for contact and interaction with appropriate regulatory bodies, clinical considerations, and a needs assessment; and
- Identification of one or more clinically meaningful device outcome measures based on input from both clinicians and patients
UG3 Scope - Examples of studies that can be proposed during the non-clinical 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;
- GLP compliant large animal model safety and/or testing of an implanted device; and
- Activities to support submission of an IDE
UH3 Scope - The UH3 phase will support a small clinical study to answer key questions about the function or final design of a device. Examples of studies that can be proposed during the clinical phase include, but are not limited to:
- Optimization of the device design with respect to the human functional anatomy;
- Identification of the most simple, reliable, and cost effective device configuration for more advanced clinical trials and eventual market approval;
- Basic proof-of-concept testing in human patients;
- Studies of the key physiological variables that may impact the function of the device in humans; and
- Initial assessments of device safety are expected, but only in conjunction with obtaining enabling data about device design or function