Device Industry Stakeholders Tell FDA To Ignore IOM Report on 510(k) Process

09.19.11
Publication: BNA By: Nathaniel Weixel

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.

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