FDA proposed a rule seeking to amend FDA’s regulations to make explicit that in vitro diagnostic products are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory.
The Supreme Court last week upended one of the underpinnings of administrative law by weakening the authority of federal health agencies to rely on technical expertise as they regulate medical products, issue coverage decisions, and respond to public health crises.
