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Compliance In Focus
Posted by John Lehmann on Wed, May 23, 2012

Changes Urged on 510(k) Plans

DisagreementDiscussion on the FDA’s 510(k) program remains a very popular topic.  According to an article in MD+DI, industry groups are urging major changes on the FDA’s draft on evaluating substantial equivalence in 510(k)s.  Not surprisingly, Public Citizens is asking the agency to delay the guidance because they feel it’s overly permissive.

In formal comments to the agency, trade association AdvaMed said the FDA hasn't made clear why the current guidance for evaluating substantial equivalence needs changing in the first place.  The association is concerned that the current uncertainty surrounding the 510(k) program and the draft guidance will impact the medical device industries ability to introduce new products into the market.

Companies like Johnson & Johnson and the Cook Group, Inc. have concerns that the proposed changes will result in an increase in 510(k) review times and an increase in the number of “not substantially equivalent” decisions.

Conversely, Public Citizens feels the proposed 510(k) guidance will allow the device industry to avoid efficacy-based trials for follow-on devices if regulators deem the changes minor.  They feel this would lead to an increase of unvetted products on the market.

So the FDA’s 510(k) review program continues to be a very hot topic. Is there room for compromise between these two opinions? Share your thoughts with us.
Photo Credit: tanakawho

Topics: AdvaMed, Public Citizens, 510(k)

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