Scientific Technical Capacity Services for Regulatory Review

The Food and Drug Administration's Center for Devices and Radiological Health seeks scientific technical capacity services to support regulatory reviews. The contractor will perform offsite work, including medical device review consultations, meeting participation, stakeholder coordination, correspondence, research, data analysis, and report writing across fields like data science, cybersecurity, diagnostics testing, digital health, epidemiology, social science, and biostatistics. Deliverables include kick-off meeting minutes, monthly reports, ad-hoc consultation documents, and meeting minutes in formats compatible with Microsoft Office 365 and Adobe Acrobat. Only onshore United States organizations are eligible to bid. All contractor personnel must obtain an FDA security clearance before performing work, and the contractor must return all government-furnished property and IT upon completion.