Today, the U.S. Food and Drug Administration (FDA) issued the draft guidance: Content of Premarket Submissions for Device Software Functions. The draft guidance is intended to reflect FDA’s most current thinking on the recommended documentation sponsors should include in premarket submissions for FDA’s evaluation of the safety and effectiveness of device software functions, including both...Read More

The FDA published the guidance document “Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions.” The guidance document is in Q&A format, and provides clarifications and recommendations to help stakeholders ensure that studies conducted in the U.S. or foreign countries comply with the new rule and revised regulations. FDA WebsiteRead More

This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. Slides from a 2010 presentation by Molly Ray of SoftwareCPR are at the link provided as a pdf. These slides provide an introduction to pre-market submissions for devices that are, or contain, software. SoftwareCPRPresentation-510ks-101510Read More