FDA Regulation of Medical Devices
Webinar: 1 CCS Credit
Some products are readily recognizable as medical devices regulated by the Food and Drug Administration, but the distinction is not always so clear with items like sunglasses, bandages, dental night guards, condoms and decorative contact lenses. Understanding whether your product is a regulated medical device and complying with the associated marketing requirements is critical to being able to successfully market such devices, reduce the chance for regulatory enforcement, avoid import delays, maintain consumer confidence, and preserve your bottom line.
- history of FDA regulation of medical devices
- how medical devices are classified
- which products are medical devices
- device marketing requirements
- enforcement activity
Shelly Garg is an attorney with Sandler, Travis & Rosenberg’s Food and Drug Law Practice Group. She represents clients across a broad range of FDA-regulated product categories, including food, beverages and dietary supplements, over-the-counter drugs, medical devices and cosmetics. She advises on strategic business planning, product development, testing and approval, labeling, advertisement and promotion, liability risk, inspections, responding to regulatory enforcement matters and related issues. Her keen insights into FDA and its inner workings have proved to be of significant value to her clients in successfully resolving matters before the agency.