The Medical Device User Fee Amendments (MDUFA) fees for FDAs 2022-2023 fiscal year are due out any day
September 9, 2022
Showing 56 to 60 of 96
September 9, 2022
August 10, 2022
July 18, 2022
March 18, 2022
What is a 510k? Who needs to submit a 510k? When is a 510K required? and more questions are going to be addressed in this document!
March 18, 2022
FDA has released a draft guidance document for industry to guide sponsors on evaluation of device software’s safety and effectiveness. “The recommendations in the new draft guidance document pertain to device software functions, including software in a medical device (SiMD) and software as a medical device (SaMD)”. The new draft guidance has in depth recommendations for every Software documentation element needed to be included in any premarket submission.