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Specialized Clinical SME (Medical Disciplines)

Active

Federal

Response Deadline11/17/2026, 07:00:00 PM UTC

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

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This subcontract opportunity through the FDA Office of Acquisition and Grant Services seeks specialized clinical subject matter experts to support prime contractors on FDA CDRH projects. The primary objective is to provide medical expertise to assist in the review of device safety and efficacy across various disciplines, including cardiovascular, neurological, orthopedic, ophthalmic, anesthesiology, pulmonology, urology, in vitro diagnostics, and radiological health devices. Selected experts will be responsible for delivering specialized clinical consultation reports and must complete conflict of interest checks. Qualified candidates must possess advanced degrees, such as an MD or PhD, in the relevant medical field. The work is associated with NAICS code 621399 and is based in Silver Spring. Interested parties should note the response deadline of November 17, 2026.

General Info

FDA CDRH seeks clinical experts for medical device safety reviews by November 17, 2026.

Agency

Department Of Health And Human Services → FDA Office Of Acq Grant Svcs

NAICS

621399 - Offices of All Other Miscellaneous Health Practitioners

Place of Performance

Silver Spring, MD, 20993, USA

Set-Aside

NONE

Documents

This scope was carved out of 75F40127Q00006.

The full solicitation package (2 documents), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

FDA/CDRH Scientific Technical Capacity for Regulatory Review

AI Contract Breakdown

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Timeline

PostedOct 30

subcontract

Response DeadlineNov 17

Submission deadline

Response Deadline

11/17/2026, 07:00:00 PM UTCin 18 days

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → FDA Office Of Acq Grant Svcs

ContactsNo contacts available

OfficeN/A

Organization / AgencyDepartment Of Health And Human Services → FDA Office Of Acq Grant Svcs

Office AddressN/A

ContactsNo contact information available

Full Description

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Provides medical subject matter expertise for prime contractors on FDA CDRH projects to assist in device safety and efficacy reviews. Consults on cardiovascular, neurological, orthopedic, ophthalmic, anesthesiology, pulmonology, urology, in vitro diagnostics, and radiological health devices. Requires advanced degrees (MD or PhD) in the specific medical field. Completes COI checks. Delivers specialized clinical consultation reports.

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