In its latest effort to provide direction and clarity to regulated industry and stakeholders, on September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule and preamble amending its medical product...more
10/1/2020
/ Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Intended Use ,
Medical Devices ,
Off-Label Use ,
Pharmaceutical Industry ,
Preamble ,
Proposed Rules ,
Repeal ,
Totality of Circumstances Test
1. Product Safety -
1.1 Legal Framework -
The main laws and regulations governing product safety in the United States include:
The Consumer Product Safety Act of 1972, 15 U.S.C. § 2051 et seq, created the Consumer...more