top of page

Draft Guidance for Device Software in Premarket Submissions - USFDA

Writer's picture: Sharan MuruganSharan Murugan

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).


“Software in a Medical Device” (SiMD)—defined as software that is a part of a medical device or controls it—and “Software as a Medical Device” (SaMD), which is software that meets the definition of a device but is not part of the overall device’s hardware.

Both SaMD and SiMD are “device software functions,” according to the agency.


This guidance identifies the software information generally necessary for evaluating the safety and effectiveness of a device in a premarket submission. The recommendations in this guidance also may help facilitate FDA’s premarket review.


This guidance describes the information that would be typically generated and documented during software development, verification, and design validation.


The least burdensome approach was applied to identify the minimum amount of information that, based on our experience, would generally be needed to support a premarket submission for a device that uses software. During the premarket review, FDA may request additional information that is needed to evaluate the submission.


Check out this guidance for more detailed information.

Comentarios


I Sometimes Send Newsletters

Thanks for submitting!

  • LinkedIn
  • Facebook
  • Twitter
  • Instagram

DISCLAIMER

The views expressed in this publication do not necessarily reflect the views of any guidance of government, health authority, it's purely my understanding. This Blog/Web Site is made available by a regulatory professional, is for educational purposes only as well as to give you general information and a general understanding of the pharmaceutical regulations, and not to provide specific regulatory advice. By using this blog site you understand that there is no client relationship between you and the Blog/Web Site publisher. The Blog/Web Site should not be used as a substitute for competent pharma regulatory advice and you should discuss from an authenticated regulatory professional in your state.  We have made every reasonable effort to present accurate information on our website; however, we are not responsible for any of the results you experience while visiting our website and request to use official websites.

bottom of page