Device Industry Stakeholders Tell FDA To Ignore IOM Report on 510(k) Process
09.19.11
Publication: BNA By:
The 510(k) premarket notification process can be improved and does not need to be abandoned, representatives from the medical device industry told the Food and Drug Administration during a Sept. 16 public meeting.
Stakeholders during the meeting said a July report from the Institute of Medicine that recommended scrapping the 510(k) process was flawed. Although not perfect, the process has a long history of protecting public health and promoting innovation, they said.






