As part of its experiential learning program, the agency’s Center for Devices and Radiological Health (CDRH) wants to send its premarket review staff out in the field to learn about industry practices, innovative technologies, regulatory impacts and needs, and how patient perspective and quality systems management advance the development and evaluation of innovative devices, and monitor the performance of marketed devices.
Interested medtech companies, academics, clinical facilities, medical device incubators and accelerators, health insurers, health technology assessment groups may apply to participate in the next round of the program by noon on Sept. 26, 2018.
The CDRH wants to train its staff in the following areas:
- Combination products
- Clinical trials/clinical research
- Device development/manufacturing/device demonstration
- Digital health/software
- Innovation/health technology assessment/market access
- InVitro diagnostics
- Quality management/quality systems
- Standards conformity assessment testing
Staff should have the chance to understand the policies, laboratory and manufacturing practices, and the challenges addressing patient perspective/input, quality system management, and other challenges that affect the device development lifecycle, the FDA said in a statement. The program is also designed to enhance communication and facilitate the premarket review process.
These formal training visits are not intended for agency staff to inspect, assess, judge, or perform a regulatory function such as compliance inspection, the FDA said. The CDRH launched the experiential learning program in 2017 and updates the areas of interest quarterly.