Why October 4th is a landmark day for the medical device industry?

October 4th is a landmark day for the medical device industry in the United States.  See, 10/4 is the final day for the public to present feedback to the agency regarding some 70+ changes to be applied to the 510(k) approval process.   Once past, the FDA will begin to make a decision.

In advance, AdvaMed has released a study hoping to minimize any changes.  According to the study, less than 1 percent of devices cleared since 1998 were involved in significant, Class I recalls that could cause serious injury or death.

Proposed change has resulted from delays and inconsistencies in the program, as witnessed by the industry itself.  Most agree that the approval process is long overdue for a review, yet AdvaMed executives are wary of wholesale change:  “Reform of the 510(k) program is appropriate, but you need scalpel, not a meat axe.”


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