The U.S. Food and Drug Administration (FDA) is the federal agency responsible for protecting public health by regulating food, drugs, medical devices, cosmetics, and more.
I U.S. Food and Drug Administration (FDA) is a federal agency of the Department of Health and Human Services. It is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods and feed, and veterinary products.
This directory serves as a resource for user manuals related to FDA systems (such as the Electronic Submission Gateway), regulatory guidelines, and official prescribing information (package inserts) for FDA-approved medical products.
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![Guidance for Biological Indicator (BI) Premarket Notification [510(k)] Submissions](https://manuals.plus/m/4f5207a2ea35ed11666d186cc8706adfb4b5b276fefa00dd4b8b9abc330b2832.png)
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The FDA ESG is an agency-wide solution for accepting electronic regulatory submissions. It enables the secure submission of regulatory information for review by the agency.
You can report adverse events or quality problems with FDA-regulated products through the MedWatch program online at www.fda.gov/medwatch or by calling 1-800-FDA-1088.
Prescribing information (package inserts) is available on the FDA website via the Drugs@FDA database. Many of these documents are also archived here for easy reference.
No, the FDA regulates the safety and efficacy of products but does not manufacture or warranty them. Warranty claims should be directed to the specific product manufacturer.