Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices
21 CFR Parts 807, 812, and 814; DEPARTMENT OF HEALTH AND HUMAN SERVICES; FDA; Docket No. FDA-2013-N-0080; ACTION: Proposed rule.
21 CFR Parts 807, 812, and 814; DEPARTMENT OF HEALTH AND HUMAN SERVICES; FDA; Docket No. FDA-2013-N-0080; ACTION: Proposed rule.
Device Good Manufacturing Practice Advisory Committee; Notice of Meeting;
DEPARTMENT OF HEALTH AND HUMAN SERVICES; FDA; Docket No. FDA-2013-N-0001; ACTION: Notice.
Consumers can play a critical role in helping the Food and Drug Administration (FDA) assure children’s access to safe medical products.
US Legislator Proposes New Office to Regulate Mobile Apps
The FDA Premarket Approval Process for Medical Devices for commercial release within the United States
Section 201(h) of the Federal Food, Drug, and Cosmetic Act defines a medical device as “any instrument, machine, contrivance, or implant, in vitro reagent that’s intended to treat, cure, prevent, mitigate, and diagnose disease in man”.