About this opportunity
AI summaryThe Food and Drug Administration's Center for Devices and Radiological Health seeks expert consultants to support regulatory review across the total medical device product lifecycle. Contractors will provide scientific, engineering, clinical, and regulatory consultations, as well as assistance with research, cybersecurity, digital health, and industry interactions across diverse specialties. This Sources Sought Notice conducts market research to identify qualified large and small business sources under NAICS code 541611, including HUBZone, service-disabled veteran-owned, women-owned, and small disadvantaged businesses. The agency does not request proposals at this time, and submission deadlines, evaluation procedures, and overall contract budgets are not yet specified.
Scope of work
- Expert consultation to review teams for 510(k), PMA, De Novo applications, presubmissions, and emergency use authorizations
- Participation in on-site or remote meetings with internal staff and external sponsors to discuss device submissions
- Development of written reviews and detailed reports
- Performance of research, regulatory science, and development of regulatory science tools
- Conducting interviews and data analysis
- Documenting analyses and drafting internal and external communications
- Continuous management of a database of expert contract support staff across diverse disciplines
- Assisting with departmental operations, logistical details, and administrative office tasks
Minimum qualifications
- Consultants must possess required education, experience, and ability to obtain FDA security clearances
- Subject matter expertise in relevant medical device scientific, engineering, or clinical specialties
- Absence of perceived ethical conflicts
Documents to include with your response
- Meeting minutes
- Monthly reports
- FDA non-disclosure agreement (3398 Form)
- Signed Rules of Behavior (ROB)
- Staff roster by name, position, e-mail address, phone number, and system access
- Site-specific safety and accident prevention plan
- Safety Data Sheets (SDS) for any hazardous materials brought to an FDA facility
- FIPS 140 validation certificates from the NIST CMVP
Key dates
- RFQ Issue Date
- TBD
- Option to Extend Services per FAR 52.217-8
- January 30, 2032, through July 29, 2032
How to submit
- Method
- Electronic
- Instructions
- Deliverables must be in a format compatible with Microsoft Office 365 and Adobe Acrobat submitted to the COR
Contract details
- Term
- One (1) base period of twelve months with four (4) option periods, plus a 6-Month Option to Extend Services per FAR 52.217-8
- Place of performance
- Both on and off-premises / remotely using FDA-furnished property, and 10903 New Hampshire Avenue
Federal notice details
- Solicitation number
- 75F40127Q00006
- Agency
- Department of Health and Human Services
- Buying office
- Food and Drug Administration › FDA Office of ACQ Grant SVCS
- Notice type
- Sources Sought
- Responses due
- Nov 17, 2026, 2:00 PM ET
- Posted on SAM.gov
- Oct 30, 2026
- NAICS
- 541611 · Administrative Management and General Management Consulting Services
- Product/service code
- R499
- Set-aside
- No Set aside used
- Place of performance
- Silver Spring, MD, 20993
- Contracting contact
- Melinda Kim
Melinda.Kim@fda.hhs.gov - Additional contact
- Nicholas Bisher
Nicholas.Bisher@fda.hhs.gov
Source: SAM.gov. Read the official notice for the complete description and current instructions.
Incumbent and award research
No incumbent history found for this requirement. The notice does not cite a current contract, and no earlier award from this buying office matches it.
Market context
Awards in the same category (Administrative Management and General Management Consulting Services). This is not this requirement's award history.
Recent similar awards: Department of Health and Human Services, NAICS 541611, performed in MD
| Vendor and award | Value | Ends |
|---|---|---|
| ABT GLOBAL LLC7571MN26F80125 · PROVIDE PROFESSIONAL EVALUATION SUPPORT SERVICES FOR ADOLESCENT PREGNANCY PREVENTION PROGR | $1.1M | Sep 28, 2031 |
| RIPPLE EFFECT COMMUNICATIONS, INC.7571PS26F80098 · LOGISTICS AND CONFERENCE SUPPORT FOR ADVISORY COMMITTEES ON PARKINSONS AND ALZHEIMERS DISE | $472.0K | Sep 22, 2031 |
| DELOITTE CONSULTING LLP75F40126F19012 · FDA UNIFIED INFORMATION GOVERNANCE PROGRAM (UIGP) SUPPORT SERVICES | $1.8M | Aug 16, 2031 |
| MANAGEMENT SOLUTIONS CONSULTING GROUP, INC.75R60225F80112 · BPH6 C 6328. PROGRAM MANAGEMENT TECHNICAL ASSISTANCE AND TRAINING: OPERATIONAL SITE VISITS | $15.8M | Feb 8, 2031 |
| WESTAT, INC.7571MN26F80116 · CHAFEE STRENGTHENING OUTCOMES FOR TRANSITION TO ADULTHOOD (SOTA) II | $2.5M | Sep 29, 2030 |
Top vendors in this category: Department of Health and Human Services, NAICS 541611, since Oct 1, 2024
4,389 contract awards in this NAICS over the period.
- 1. DELOITTE CONSULTING LLP$326.2M
- 2. GUIDEHOUSE INC.$208.0M
- 3. BOOZ ALLEN HAMILTON INC$186.8M
- 4. RESEARCH TRIANGLE INSTITUTE$166.5M
- 5. MAXIMUS FEDERAL SERVICES, INC.$158.5M
Source: USAspending.gov federal award data (U.S. federal public data). A contract is called the incumbent only when the notice or its documents cite it by number.