A House bill introduced this month that would allow the FDA to refuse 510(k) submissions with designs based on previously recalled products has incited debate between the industry and regulators. Jeffrey Shuren, director of the FDA's device center, said the bill would close a "loophole" that has called into question certain medical device approvals. The Advanced Medical Technology Association, however, maintains the bill would put more strain on companies already facing lengthy delays in FDA reviews, spokeswoman Wanda Moebius said.
Proposal to restrict 510(k) submissions sparks debate
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