What is the FDA?
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FDA Approval and Certification
What is the FDA?
The FDA is the agency of the United States government responsible for dietary supplements, food, pharmaceuticals, blood products, biological medical products, radiation-emitting devices, medical devices, cosmetics, and veterinary products. The acronym stands for the US Food and Drug Administration. Established in 1862, it sits within the US Department of Health and Human Services.
The FDA (US Food and Drug Administration) is responsible for drugs and food products, along with biomedical devices, medical equipment, radiation-emitting products, and cosmetic products. With close to 10,000 staff, the agency analyses and verifies products that fall within its scope before they reach the US market.
Why the FDA matters for exporters
For a manufacturer that wants to reach the US market, FDA registration is the gate. The registration confirms that a manufacturer has provided the agency with the data it requires about the facility, the product, and the person responsible. Without that registration, a shipment will not clear US customs.
How Sistem Patent Kalite supports FDA projects
Sistem Patent Kalite handles FDA registration, renewals, US Agent appointments, and device-specific submissions such as 510(k). Clients have a single consultancy to talk to for the full FDA cycle rather than running three separate vendor relationships.
