The Inner Circle

FDA Draft for Comment: Content of Premarket Submissions for Device Software Functions

  • 1.  FDA Draft for Comment: Content of Premarket Submissions for Device Software Functions

    Posted 23 days ago
      |   view attached
    Hi All,

    @James Angle

    The FDA just published for comment - Draft Guidance for Content of Premarket Submissions for Device Software Functions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 section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The recommendations in this guidance document pertain to device software functions, including software in a medical device (SiMD) and software as a medical device (SaMD). When final, this document will replace FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices3 21 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.

    Submit electronic comments to https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food and Drug Administration, 5630 Fishers Lane,
    Room 1061, (HFA-305), Rockville, MD 20852. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.
    ​​

    ------------------------------
    Michael Roza CPA, CISA, CIA, MBA, Exec MBA
    ------------------------------