FDA/CDRH Scientific Technical Capacity for Regulatory Review

This is not a solicitation announcement.  This is a Sources Sought Notice (SSN) only. This SSN is issued solely for market research and planning purposes – it does not constitute a Request for Quotation (RFQ) or a promise to issue an RFQ in the future. Further, the SSN does not commit the Government to contract for any supply or service whatsoever. The FDA is not seeking proposals and will not accept any unsolicited proposals. Responders are advised that the U.S. Government will not pay for any information or administrative costs incurred in response to this SSN; all costs associated with responding to this SSN will be solely at the expense of the interested respondents. Not responding to this SSN does not preclude participation in any future RFQ, if issued. The purpose of this SSN is to gain knowledge of potential qualified vendors, including large business sources, small business sources and their size classifications (i.e., HUBZone 8(a), 8(a), HUBZone, Service-Disabled Veteran-Owned, Veteran-Owned, Women-Owned Small Business, and Small Disadvantaged Business) relative to the North American Industry Classification System (NAICS) code.

Responses to this SSN will be used by the Government to make appropriate determinations about potential sources. 

Project Title: FDA/CDRH Scientific Technical Capacity for Regulatory Review

Background:  To assist the U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) in fulfilling its mission, CDRH seeks expert consultants to assist CDRH’s Offices with regulatory review across the total product lifecycle. CDRH requires consultants that have skilled experience to assist with medical device regulatory review work and supporting scientific activities, such as research, cybersecurity and digital health consultations, regulatory consultations and auditing, and interacting with industry and patients. The CDRH requires consultants that have sufficient skilled capacity in many science, engineering, and clinical specialties, including Anesthesiology, Biology, Biomedical Engineering,  Chemistry, Clinical laboratory testing, Computer Science and Engineering, Consumer Safety, Cybersecurity, Data Science, Dentistry, Digital Health, Epidemiology, Gastroenterology, General Engineering, Health Science, Infectious Diseases, Interdisciplinary Engineer/Scientist, Molecular testing, Neurology, Optics, Patient Engagement, Physics, Psychiatry, Public Health, Pulmonology, Reprocessing medical devices, Social Scientist, Software Engineering, Statistics and Biostatistics, Sterilization, Toxicology, Urology, Veterinary Medicine, and Virology.

Objective: The primary objective of this effort is to provide the CDRH with a vehicle to acquire the support services of advanced professional and scientific consultants to assist CDRH’s Offices with regulatory review across the total product lifecycle, including the supporting scientific, engineering, clinical, and regulatory activities. The services provided will be critical scientific expertise and capacity in support for the evaluation of the continued performance, safety, and effectiveness, with respect to devices approved, cleared, licensed, or authorized for use for the treatment, prevention, or diagnosis of medical conditions by the FDA.  

Instructions for Responses to this SSN: Your responses to the questions provided below will assist the Government in selecting the appropriate acquisition method.  Page limit: Maximum 15 pages (font size Times New Roman 11 or larger). In addition to responses to the below questions, each vendor responding to this SSN shall also fill out and provide responses to “Attachment B-Vendor Feedback Form.” The Vendor Feedback Form is not included in the 15-page limit. A copy of the company capability statement will also be accepted (but not in place of the responses to the below questions or the Vendor Feedback Form). The anticipated period of performance consists of one (1) Base Year and four (4) Option Years. Responses to this SSN must include company name, address, point of contact, size of business pursuant to the NAICS code, and must respond to the following questions:

1. Is your business a small business under the NAICS code?
2. Does your firm qualify as a Small Disadvantaged Business?
3. If disadvantaged, specify if your firm is certified under Section 8(a) of the Small Business Act?
4. Are you considered a certified HUBZone firm?
5. Are you considered Woman-Owned or operated business?
6. Are you a certified Service-Disabled Veteran-Owned or Veteran-Owned business?

Included is a draft Statement of Work that is inclusive of the anticipated Task Areas (“Attachment A-Draft Statement of Work”).

• All interested parties can provide written opinions/questions on the draft Statement of Work. 
• All opinions/questions expressed should focus on strengthening the draft Statement of Work Tasks to ensure industry understands and comprehends the government’s requirements. 

Responses to this SSN shall be submitted via e-mail to Melinda Kim, Contract Specialist, at Melinda.Kim@fda.hhs.gov, (with a CC: to Nicholas Bisher, Contracting Officer, at Nicholas.Bisher@fda.hhs.gov), by 2:00 PM Eastern Standard Time on November 17, 2026. The subject line of the e-mail shall reference, “Vendor Response to SSN 75F40127Q00006.” 

After a review of the received responses, a formal solicitation may be published on SAM.gov or on GSA eBuy.  No solicitation is currently available.  This is not a request for quotation and in no way obligates the Government to award any contract.  Responses to this SSN will not be considered adequate responses to the solicitation, a request to be added to a prospective offerors list, or a request to receive a copy of the solicitation. 

Attachments:

1. Attachment A-Draft Statement of Work
2. Attachment B-Vendor Feedback Form