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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.