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For more information, see the guidance document, Electronic Submission Template for Medical Device 510(k) Submissions. For hand deliveries (in person) to the CDRH White Oak Campus building 66, please contact 301-796-6597 for instruction.

Drugs are tested on people to make sure they are safe and effective. FDA review teams thoroughly examine all of the submitted data related to the drug or device and make a decision to approve or not to approve it. FDA monitors all drug and device safety once products are available for use by the public.

An agency in the U.S. federal government whose mission is to protect public health by making sure that food, cosmetics, and nutritional supplements are safe to use and truthfully labeled.

Food and Drug Administration Website: Food and Drug Administration (FDA) Contact: Contact the Food and Drug Administration. Report a Problem with a Product. Toll Free: 1-888-INFO-FDA (1-888-463-6332) Forms: Food and Drug Administration Forms. Popular Services from Food and Drug Administration. FDA recalls and safety alerts.

1. During Normal Business Hours (8 a.m. - 4:30 p.m. ET, weekdays) For general questions, or if you are unsure of who to contact, contact the Patient Affairs Staff at 301-796-8460 or patientaffairs@fda.hhs.gov.

The FDA is responsible for protecting public health by regulating human drugs and biological products, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation.

The United States (US) Food and Drug Administration (FDA) is the organization responsible for protecting public health by ensuring that the drugs available on the US market meet certain standards for both safety and efficacy.