MedTech Dive November 4, 2021
Nick Paul Taylor

Dive Brief:

  • FDA has belatedly published draft guidance on the content of premarket submissions for device software functions, moving it a step closer to the replacement of 16-year-old guidance.
  • The draft covers the documents sponsors should include in submissions to enable FDA to evaluate the safety and effectiveness of device software functions. The guidance applies to all types of premarket submissions and includes both software in and software as a medical device (SiMD/SaMD).
  • FDA committed to releasing a draft replacement for the current 2005 guidance as part of the MDUFA IV agreement but failed to deliver the document by the end of its 2019 financial year as planned. Bradley Merrill Thompson, attorney at Epstein Becker Green, said the new...

Today's Sponsors

LEK
ZeOmega

Today's Sponsor

LEK

Continue Reading

 
Topics: FDA, Govt Agencies, Medical Devices
Related Articles:
Early tests of H5N1 prevalence in milk suggest U.S. bird flu outbreak in cows is widespread
Bird Flu (H5N1) Explained: Here’s What To Know—And Why Scientists Are Concerned
2023 Had Most Food Recalls Since Start Of COVID-19 Pandemic, Report Finds
Exo adds FDA-cleared AI tools to handheld ultrasound system
Scopio Labs gains De Novo clearance for AI bone marrow analysis software and more FDA clearances

Share This Article