what is the fda definition of over-the-counter medical devices
The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments.ew drugs receive extensive scrutiny before FDA approval in a process called a New Drug Application (NDA). New drugs are available only by prescription by default. A change to over-the-counter (OTC) status is a separate process, and the drug must be approved through an NDA first.