FDA/CDRH Scientific Technical Capacity for Regulatory Review

Estimated Value: $15,000,000
Open 14 days left MarylandProfessional Servicesrfi
Oct 30, 2026
Nov 17, 2026 1:00 PM
Professional Services
rfi
541611
small business
AI Summary
This is a Sources Sought Notice (SSN) for the FDA's Center for Devices and Radiological Health (CDRH) to identify potential vendors with scientific and technical capacity for regulatory review of medical devices. CDRH is seeking expert consultants with skills in various science, engineering, and clinical specialties to assist with regulatory review across the total product lifecycle. This notice is for market research only and does not constitute a solicitation.
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Source: USAspending.gov. Similar work, not necessarily this exact contract.

Line Items
ItemQtyUnitEst. Unit PriceEst. TotalCategory
Expert Consultant Services for Medical Device Regulatory Review (Anesthesiology) 1 lot $500,000.00 $500,000.00 Professional Services
Expert Consultant Services for Medical Device Regulatory Review (Biology) 1 lot $500,000.00 $500,000.00 Professional Services
Expert Consultant Services for Medical Device Regulatory Review (Biomedical Engineering) 1 lot $500,000.00 $500,000.00 Professional Services
Expert Consultant Services for Medical Device Regulatory Review (Chemistry) 1 lot $500,000.00 $500,000.00 Professional Services
Expert Consultant Services for Medical Device Regulatory Review (Clinical Laboratory Testing) 1 lot $500,000.00 $500,000.00 Professional Services
Expert Consultant Services for Medical Device Regulatory Review (Computer Science and Engineering) 1 lot $500,000.00 $500,000.00 Professional Services
Expert Consultant Services for Medical Device Regulatory Review (Consumer Safety) 1 lot $500,000.00 $500,000.00 Professional Services
Expert Consultant Services for Medical Device Regulatory Review (Cybersecurity) 1 lot $500,000.00 $500,000.00 Professional Services
Expert Consultant Services for Medical Device Regulatory Review (Data Science) 1 lot $500,000.00 $500,000.00 Professional Services
Expert Consultant Services for Medical Device Regulatory Review (Dentistry) 1 lot $500,000.00 $500,000.00 Professional Services
Expert Consultant Services for Medical Device Regulatory Review (Digital Health) 1 lot $500,000.00 $500,000.00 Professional Services
Expert Consultant Services for Medical Device Regulatory Review (Epidemiology) 1 lot $500,000.00 $500,000.00 Professional Services
Expert Consultant Services for Medical Device Regulatory Review (Gastroenterology) 1 lot $500,000.00 $500,000.00 Professional Services
Expert Consultant Services for Medical Device Regulatory Review (General Engineering) 1 lot $500,000.00 $500,000.00 Professional Services
Expert Consultant Services for Medical Device Regulatory Review (Health Science) 1 lot $500,000.00 $500,000.00 Professional Services
Expert Consultant Services for Medical Device Regulatory Review (Infectious Diseases) 1 lot $500,000.00 $500,000.00 Professional Services
Expert Consultant Services for Medical Device Regulatory Review (Interdisciplinary Engineer/Scientist) 1 lot $500,000.00 $500,000.00 Professional Services
Expert Consultant Services for Medical Device Regulatory Review (Molecular Testing) 1 lot $500,000.00 $500,000.00 Professional Services
Expert Consultant Services for Medical Device Regulatory Review (Neurology) 1 lot $500,000.00 $500,000.00 Professional Services
Expert Consultant Services for Medical Device Regulatory Review (Optics) 1 lot $500,000.00 $500,000.00 Professional Services
Expert Consultant Services for Medical Device Regulatory Review (Patient Engagement) 1 lot $500,000.00 $500,000.00 Professional Services
Expert Consultant Services for Medical Device Regulatory Review (Physics) 1 lot $500,000.00 $500,000.00 Professional Services
Expert Consultant Services for Medical Device Regulatory Review (Psychiatry) 1 lot $500,000.00 $500,000.00 Professional Services
Expert Consultant Services for Medical Device Regulatory Review (Public Health) 1 lot $500,000.00 $500,000.00 Professional Services
Expert Consultant Services for Medical Device Regulatory Review (Pulmonology) 1 lot $500,000.00 $500,000.00 Professional Services
Expert Consultant Services for Medical Device Regulatory Review (Reprocessing Medical Devices) 1 lot $500,000.00 $500,000.00 Professional Services
Expert Consultant Services for Medical Device Regulatory Review (Social Scientist) 1 lot $500,000.00 $500,000.00 Professional Services
Expert Consultant Services for Medical Device Regulatory Review (Software Engineering) 1 lot $500,000.00 $500,000.00 Professional Services
Expert Consultant Services for Medical Device Regulatory Review (Statistics and Biostatistics) 1 lot $500,000.00 $500,000.00 Professional Services
Expert Consultant Services for Medical Device Regulatory Review (Sterilization) 1 lot $500,000.00 $500,000.00 Professional Services
Expert Consultant Services for Medical Device Regulatory Review (Toxicology) 1 lot $500,000.00 $500,000.00 Professional Services
Expert Consultant Services for Medical Device Regulatory Review (Urology) 1 lot $500,000.00 $500,000.00 Professional Services
Expert Consultant Services for Medical Device Regulatory Review (Veterinary Medicine) 1 lot $500,000.00 $500,000.00 Professional Services
Expert Consultant Services for Medical Device Regulatory Review (Virology) 1 lot $500,000.00 $500,000.00 Professional Services
Estimated Bid Value$15,000,000.00

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📎 Attachment_A_-_Draft_Statement_of_Work.pdf View
📎 Attachment_B_-_Vendor_Feedback_Form.docx View
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