FDA Medical Devices Regulation Checklist


This FDA medical devices regulation checklist addresses various measures that counsel representing a medical device company should take and issues that should be considered with respect to the marketing and sale of medical devises to be compliant with the regulations implemented and enforced by the Food and Drug Administration (FDA). The checklist addresses issues including the classification of medical device products; registration of medical device establishments, premarket approvals, the review of cosmetic labels and information presentation, intellectual property concerns, advertising and marketing, good manufacturing practices, and reporting obligations.