This webinar is intended to discuss regulatory requirements for FDA 510(k)s: in particular, 510K) preparation, submission and a successful clearance under the current FDA situation.
The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) prescribes the premarket notification requirements.
The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) prescribes the premarket notification requirements.
