FDA Medical Devices Regulations | Practical Law

FDA Medical Devices Regulations | Practical Law

A Practice Note discussing how the Food and Drug Administration (FDA) regulates the production and sale of medical devices in the US under the Federal Food, Drug, and Cosmetic Act (FDCA) and other federal laws. This Note discusses, among other things, rules related to FDA establishment registration, premarket approvals, manufacturing controls, and product labeling.

FDA Medical Devices Regulations

Practical Law Practice Note 7-613-9907 (Approx. 23 pages)

FDA Medical Devices Regulations

by Practical Law Commercial Transactions
Maintained • USA (National/Federal)
A Practice Note discussing how the Food and Drug Administration (FDA) regulates the production and sale of medical devices in the US under the Federal Food, Drug, and Cosmetic Act (FDCA) and other federal laws. This Note discusses, among other things, rules related to FDA establishment registration, premarket approvals, manufacturing controls, and product labeling.