FDA/CDRH Scientific Technical Capacity for Regulatory Review
This Sources Sought Notice is for FDA/CDRH market research only, not a solicitation, and the FDA is not seeking or accepting proposals. CDRH seeks qualified vendors, including large and small businesses across specified socioeconomic classifications, to provide expert scientific, engineering, clinical, and regulatory-review support across the medical-device total product lifecycle. Required expertise spans numerous specialties such as biomedical engineering, cybersecurity/digital health, clinical laboratory and molecular testing, epidemiology, statistics, sterilization, toxicology, and multiple medical and scientific disciplines. The anticipated period of performance is one base year plus four option years, and interested vendors are asked to provide capability and socioeconomic information plus feedback on the draft statement of work. After review, a formal solicitation may be posted on SAM.gov or GSA eBuy.