Referencing the definition of “device” in the Federal Food, Drug, and Cosmetic Act in guidance, regulatory documents, communications, and other public documents: guidance for industry and Food and Drug Administration staff

Referencing the definition of “device” in the Federal Food, Drug, and Cosmetic Act in guidance, regulatory documents, communications, and other public documents: guidance for industry and Food and Drug Administration staff

Collection:
Health Policy and Services Research
Contributor(s):
Center for Devices and Radiological Health (U.S.), issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Devices and Radiological Health, November 14, 2022
Language(s):
English
Format:
Text
Subject(s):
Government Regulation
Medical Device Legislation
Terminology as Topic
United States
United States. Food and Drug Administration
United States.
Genre(s):
Guideline
Technical Report
Abstract:
The U.S. Food and Drug Administration (FDA or the Agency) recommends the consistent use of terms and definitions of legal significance. In light of recent amendments to section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as a result of the enactment of the Safeguarding Therapeutics Act, FDA is issuing this guidance to promote clarity regarding references to the terms “device” and “counterfeit device.” In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (5 pages))
NLM Unique ID:
9918590086006676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918590086006676