US FDA (US Food and Drug Administration)

The US Food and Drug Administration (FDA) is the federal regulatory authority responsible for ensuring the safety, effectiveness, and quality of medical devices, in vitro diagnostics (IVDs), pharmaceuticals, vaccines, biologics, blood products, food, dietary supplements, cosmetics, radiation-emitting electronic products, and tobacco products. The FDA operates under the Department of Health and Human Services. It enforces the Federal Food, Drug, and Cosmetic Act of 1938, along with subsequent amendments. FDA develops guidance documents to support regulatory consistency and publishes new regulations and rules in the Federal Register, which are codified in the Code of Federal Regulations (CFR) when they become final.

Once products are on the market, the FDA ensures their performance through post-market surveillance, adverse event reporting systems, recalls, and safety alerts. It enforces current manufacturing requirements by inspecting facilities in the US and abroad for compliance with the Quality Management System Regulation (QMSR), which has been in effect since February 2, 2026. See our US QMSR compliance service overview for implementation support. The agency also regulates clinical trials, oversees product labeling and advertising, and works with US Customs and Border Protection to control the import and export of regulated goods.

When was the US FDA established?

The US FDA began regulatory activities in 1906 when the Pure Food and Drugs Act was passed. It was named the US FDA in 1930.

What is the difference between the US FDA and the Center for Devices and Radiological Health?

The Center of Devices and Radiological Health (CDRH) is the center within the FDA responsible for medical device oversight. This includes pre-market review of medical devices to evaluate safety and efficacy before they can be marketed. Most devices are required to submit a Premarket Notification 510(k) for review, depending on their risk classification. Most high-risk devices are required to submit a more extensive Premarket Approval (PMA).

Does US FDA charge fees?

Yes, the US FDA charges fees for medical device applications (PMAs and 510(k) submissions) and annual establishment registrations to supplement congressional funding of its operating costs. Small businesses may be eligible for reduced fees. Fees are updated annually by US Congress; current user fees can be found here.

How can I contact the US FDA?

The best way to contact the US FDA depends on the nature of your query. If you have a general inquiry or need to report a product problem, contact FDA by phone at 1-888-INFO-FDA (1-888-463-6332). To report a product problem online, visit the Safety Reporting Portal via SmartHub.

Website: US FDA
Address: 10903 New Hampshire Ave, Silver Spring, MD 20993
Phone: (800) 638-2041
Email: DICE@fda.hhs.gov