Content of Premarket Submissions for Device Software Functions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Content of Premarket Submissions for Device Software Functions." This guidance document is intended to provide information regarding the recommended documentation sponsors should include in premarket submissions for FDA's evaluation of the safety and effectiveness of device software functions, which are functions that meet the definition of a device under the Federal Food, Drug, and Cosmetic Act (FD&C Act). When final, this document will replace FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, and it will update FDA's thinking related to the documentation FDA recommends sponsors include for the review of device software functions in premarket submissions. This draft guidance is not final nor is it in effect at this time.