The Food, Drug, and Cosmetic Act (FDCA or the Act) governs safety, efficacy, and labeling over drugs, cosmetics, dietary supplements, medical devices, and other consumer products. 21 U.S.C. § 393(b). The FDCA grants the Food and Drug Administration (FDA) the primary power to enforce the Act (id. § 393(a)), including whether drugs, cosmetics, dietary supplements, and medical device manufacturers properly label their products to avoid misleading their customers. See, e.g., id. §§ 343, 352, 362, 387c. The FDCA expressly precludes […]

A medtech startup typically focuses on two key legal needs: (1) ensuring that its technology has proper and thorough intellectual property protection, and (2) outlining a detailed pathway for FDA clearance. Those two priorities are understandable.

The areas of intellectual property protection and a regulatory pathway are threshold issues that every potential investor wants addressed before funding a company. The hypothetical risk of future product liability litigation is not as high a priority for startup […]