The Regulation of Medical Software under the Food, Drug and Cosmetic Act: A Perspective from the Government.

FDA is currently developing a policy regarding application of the Food, Drug and Cosmetic Act in the medical software marketplace. It should be available for review in draft form in summer or early fall 1986. This paper reviews the Agency's device regulation program and its implications for any medical software products deemed to be medical devices under that policy. It is anticipated that implementation will proceed smoothly, without undue delay or expense to industry or government.