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AdvaMed Opposes FDA Reclassification Proposal


Posted in Regulatory and Compliance by Jamie Hartford on September 2, 2014

The medtech trade group says the agency's proposal would substantially expand the scope of devices requiring PMA approval. 


By Jim Dickinson

Medical technology industry trade association AdvaMed says it is “gravely concerned regarding the wide-ranging impact” of a revised regulation proposed by FDA governing the classification and reclassification of medical devices.

Stay on top of all the goings-on at FDA by attending the MD&M Minneapolis conference October 29 & 30, 2014.

In a recently posted comment, the group says the proposed changes “are not limited to FDA interpretation and implementation of provisions related to the FDA Safety and Innovation Act or clarifying provisions, but they create fundamental changes to the classification process for medical devices.”

In particular, the letter says, the proposal substantially rewrites the definition of Class III and sets forth new categories for it. The changes would substantially expand the scope of devices requiring PMA approval, the association says.

“In [our] review of the proposed estimates, we recommend reexamination and reconsideration to reflect realistic, accurate estimates of the time and costs associated with the preparation and completion of petitions related to new and existing products, including data gathering and reporting for Class [III] (PMA) products,” the comment says.

“We note the cost of supporting data for reclassification appears significantly underestimated. Furthermore, we estimate substantial increase in the number of required PMAs as regulatory challenges will only increase for manufacturers navigating the classification process.”

The letter also includes specific comments on the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions.

Stay on top of all the goings-on at FDA by attending the MD&M Minneapolis conference October 29 & 30, 2014.

Jim Dickinson is MD+DI's contributing editor. 

[image courtesy of CHRIS ROLL/FREEDIGITALPHOTOS.NET]


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