FDA Regulation: Cosmetic Product or Medical Device?
Webinar: 1 CCS Credit
Recent enforcement activity against cosmetic device manufacturers and distributors demonstrates that the Food and Drug Administration may regard products marketed for cosmetic purposes as medical devices. This webinar will explore what makes products cross that barrier, the kinds of products generally regarded as medical devices, and regulatory requirements for devices and cosmetics.
- when FDA clearance or approval may be required for a cosmetic product
- differences between cosmetic product claims and medical device indications
- requirements for marketing a device
- FDA enforcement activity
- best practices
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 in 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.