AdvaMed opposes proposed Class IIb category

The FDA has been releasing reports from study groups as to how best overhaul the approval process for medical devices.  One report focuses on ways to strengthen and clarify the 510(k) process for devices that do not need to undergo a full premarket approval (PMA) review.  The reports can be found here.

Last week, the Advanced Medical Technology Association (AdvaMed) said in a statement that it was reviewing the FDA’s recommendations.  The group said it was pleased to note on first reading, though, that the 510(k) report incorporates AdvaMed recommendations on targeting special requirements for a small subset of class II 510(k) devices.

Now, however, AdvaMed has raised objections to some of the proposals found in the reports.  One FDA proposal is to establish the Class IIb category for medium-risk devices.  According to the report, “delineating between Class IIa & Class IIb would not reconfigure the current, three-tiered device classification system established by statute; it would represent only an administrative distinction.”

But Advamed believes the new category could lead to the extensive reclassification of products and pose additional requirements to device firms.  According to AdvaMed EVP Janet Trunzo, “The FDA’s proposal goes beyond what we were thinking.”

So will this be the big topic of conversation amongst leading device CEO’s during next months conference in Washington DC?

AdvaMed 2010: The Medtech Conference.

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