The Food and Drug Administration spends roughly $3 billion annually on contracts. Most of that money goes to scientific testing, IT services, professional services, and facilities support — categories where small and diverse businesses compete successfully. FDA sits inside the Department of Health and Human Services, which means it operates under the same small business contracting goals as the rest of HHS. In FY2023, HHS as a whole awarded more than $4 billion to small businesses. FDA contributes a meaningful share of that.
If you have a business in laboratory testing, regulatory science consulting, software development, or facilities services, FDA is a realistic target. Here is how to get in front of the right buyers.
What FDA buys
FDA's largest procurement categories break into a few buckets.
Scientific and technical services account for a significant share of the spend. This includes laboratory testing, environmental sampling, food safety testing, and drug analysis. FDA runs labs across the country and outsources specialized testing regularly. Contract sizes in this category range from under $100,000 for small testing projects to multi-million dollar indefinite delivery contracts for ongoing analytical work.
Information technology services are the second major category. FDA has invested heavily in modernizing its regulatory systems, electronic submission platforms, and data infrastructure. Work here includes systems development, cybersecurity, data analytics, cloud migration, and IT support. Many of these contracts run $1 million to $10 million over a base period with options.
Professional and management consulting covers regulatory affairs consulting, program evaluation, communications support, and organizational development. FDA also buys training development and delivery services for internal staff and regulated industry stakeholders.
Facilities and logistics round out the spend. Building operations, janitorial services, food services at FDA campuses, and supply logistics are all contracted out. These contracts tend to be longer-term and locally sourced, which creates opportunity for businesses near FDA's White Oak campus in Silver Spring, Maryland, or its field offices around the country.
Primary NAICS codes
Three NAICS codes cover a large portion of FDA's outsourced work:
541380 — Testing Laboratories. This covers all forms of scientific and analytical testing. If your business does environmental testing, product safety testing, chemical analysis, or biological assays, this is your primary code.
541690 — Other Scientific and Technical Consulting Services. Regulatory science consulting, risk assessment, toxicology consulting, and similar advisory services fall here. FDA relies heavily on outside expertise for specialized scientific questions.
541519 — Other Computer Related Services. This captures IT work that doesn't fit neatly into software publishing or data processing, including custom software development, IT consulting, and systems integration.
If you are doing IT work, also review 541512 (Computer Systems Design Services) and 541511 (Custom Computer Programming Services), both of which appear in FDA's contracting history.
How to register and get into the ecosystem
Before FDA can pay you, you need to complete three registrations.
First, register your business in SAM.gov. This is the federal supplier database and the gateway to all federal contracting. The registration is free and takes 10 to 14 business days to activate. You will need your EIN, your NAICS codes, and your business banking details for electronic funds transfer. You must renew SAM.gov annually or your registration lapses and you become ineligible for awards.
Second, get your Unique Entity ID. SAM.gov now issues UEIs directly as part of the registration process. This replaced the DUNS number system in 2022.
Third, check whether you qualify for any socioeconomic certifications. FDA, like all HHS components, uses set-aside contracts to direct work toward small businesses, 8(a) firms, women-owned small businesses (WOSB), service-disabled veteran-owned small businesses (SDVOSB), and HUBZone firms. Getting certified before you pursue FDA work opens doors to sole-source and restricted competitions that larger companies cannot enter.
The SBA handles 8(a), WOSB, SDVOSB, and HUBZone certifications at certify.sba.gov. Processing times vary by program but plan for 60 to 90 days for most certifications.
FDA's small business office
FDA's Office of Acquisitions and Grants Management (OAGM) manages contracting. Within that structure, the Small Business Program coordinates outreach, matchmaking, and set-aside goal tracking.
The FDA Small Business Representative is your first point of contact. This person tracks set-aside utilization, helps small businesses understand upcoming requirements, and connects vendors with program offices when there is a clear fit. You can find the current contact information on the FDA website under the "Doing Business with FDA" section. Contact this office before you start submitting capabilities statements cold.
FDA also participates in HHS industry days, matchmaking events, and vendor outreach sessions. These events are listed on the HHS Office of Small and Disadvantaged Business Utilization (OSDBU) calendar. HHS's OSDBU sits above FDA and works across all HHS operating divisions, so connecting there gives you visibility into opportunities across FDA, NIH, CDC, and CMS simultaneously.
Set-aside and diversity opportunities
FDA uses the full range of set-aside vehicles. Contracts under the simplified acquisition threshold ($250,000) are automatically set aside for small businesses when two or more small businesses can compete. Above that threshold, contracting officers can set aside work for specific small business categories.
FDA awards contracts through its own contracting shop and also through government-wide acquisition contracts (GWACs) and HHS-specific vehicles. The HHS IT Acquisition and Assessment Center (AITAC) manages several IT contract vehicles that FDA uses regularly. If you do IT work, getting onto an AITAC vehicle expands your FDA reach considerably.
For 8(a) firms, FDA can issue sole-source awards up to $4.5 million for services and $7 million for manufacturing without a competitive process. This is significant. An 8(a) certification combined with a relevant NAICS code and a targeted outreach effort to FDA program offices is one of the cleaner paths to a first award.
One practical tip for a first contract
Target FDA's field offices, not just the White Oak headquarters.
FDA operates district offices in Chicago, New York, Atlanta, San Francisco, and elsewhere. These offices contract locally for services that headquarters rarely sees. Building inspections, laboratory support at regional labs, local courier and logistics services, and facility maintenance are all procured at the district level. The contracting volumes are smaller, which means less competition, faster procurement timelines, and a realistic shot for a business that is new to federal work.
Search USASpending.gov for "Food and Drug Administration" filtered to your state. Look at what local firms have been paid, what the contract amounts are, and which NAICS codes appear. That tells you exactly what the nearby FDA office buys and what the going rates look like. Then contact the local district office directly to introduce your business and ask about upcoming requirements. Most federal buyers prefer to buy from vendors they know when the rules allow it.
Getting started
Register in SAM.gov today if you have not already done so. Pull your socioeconomic certifications from SBA if you qualify. Then contact FDA's Small Business Representative through the FDA website to introduce your business and ask about the next industry day or matchmaking event. The agency spends $3 billion annually. Some of it should be yours.
