What We Do | FDA - U.S. Food and Drug Administration
The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical ...
Classification of Products as Drugs and Devices and Additional Issues
Conceptually, all FDA-regulated medical products meet the definition of “drug” under section 201(g) of the FD&C Act, due to the broader scope of the drug definition.
Drugs@FDA Glossary of Terms | FDA - U.S. Food and Drug …
What’s the meaning of this? Welcome to the Drugs@FDA glossary of terms. From abbreviated new drug application to therapeutic equivalence codes, FDA defines it.
U.S. Food and Drug Administration
The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by …
How to Determine if Your Product is a Medical Device | FDA - U.S.
Step 1: Determine if your product meets the definition of a medical device per Section 201(h) of the Food, Drug & Cosmetic Act. Step 2: Determine if an appropriate product classification …
CFR - Code of Federal Regulations Title 21 - Food and Drug …
Aug 30, 2024 · FDA means the Food and Drug Administration. Food means food as defined in section 201(f) of the Federal Food, Drug, and Cosmetic Act and includes raw materials and …
Food and Drug Administration The Food Code is a model for safeguarding public health and ensuring food is unadulterated and honestly presented when offered to the consumer.
FDA Fundamentals | FDA - U.S. Food and Drug Administration
What is FDA Basics for Industry? FDA at a Glance: Overview of FDA responsibilities and resources; FDA History. When and why was FDA formed? How did the Federal Food, Drug, …
What is Digital Health? | FDA - U.S. Food and Drug Administration
The following are topics in the digital health field on which the FDA has been working to provide clarity using practical approaches that balance benefits and risks: Software as a Medical …
The Food and Drug Administration Safety and Innovation Act of 2012 provides that FDA may consider “. . . epidemiological, pathophysiological, therapeutic, pharmacologic, or other