Kids Have Problems With Medical Products?

Consumers can play a critical role in helping the Food and Drug Administration (FDA) assure children’s access to safe medical products.

Overview of Regulatory Requirements

The FDA Premarket Approval Process for Medical Devices for commercial release within the United States

Definition of a Medical Device

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”.