By -
SebastianFeye
In September of 2018, the FDA took their first step to improve and modernize the process of a 510(k) electronic submission. This commitment was established as part of the Food and Drug Administration Safety and Innovation Act (FDASIA) that was enacted on July 9, 2012, amending the FD&C Act by adding section 745A. As part of this Act, a program
Tagged : device, eCopy, electronic, FDA, Guidance, Health Canada, medical, modernization, PDF, Pilot, premarket, process, Program, submission
