OTC and Consumer Products
We have significant experience and expertise in helping clients navigate the line between consumer health & wellness products and traditional medical devices, along with work on consumer and OTC medical devices. Some examples of our recent work in this space include:
- Consumer sleep monitor and coaching system – Regulatory strategy and guidance
- Health & wellness bracelets, accessories, and other consumer products – regulatory strategies, labeling and website reviews
- Laser-based hair removal and hair growth – regulatory strategy, FDA submissions, labeling reviews
- Wound care products – Regulatory strategy, guidance to meet regulatory requirements when transitioning from Rx to OTC use
