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This guidance is intended for farms subject to the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety Rule) (21 CFR Part 112).

This guidance provides recommendations for 510(k) submissions for peripheral percutaneous transluminal angioplasty (PTA) and specialty catheters.

The purpose of this document is to provide guidance on the types of fees FDA is authorized to collect under the Animal Drug User Fee Act of 2003 and how to request waivers and reductions from these fees.

On April 11, 2023, the U.S. Fish and Wildlife Service (Service) issued a final rule listing the bracted twistflower (Streptanthus bracteatus), a wildflower native to Texas, as...

This guideline informs industry of data that demonstrates a teat antiseptic product is safe and effective for the cow, and fulfills human food safety, manufacturing, and environmental requirements.

Guidance for Industry - A Risk-Based Approach to Monitoring of Clinical Investigations, Questions and Answers

Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act

Learn more about who submits tobacco health documents to FDA, compliance policies, information to include, and how and when to submit health documents.

FDA provides guidance for tobacco manufacturer registration and product listing.

The FDA updated draft guidance for Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers which revamps recommendations from 2017 on the requirements of 21 CFR Part 11 and use of technologies in clinical investigations.