4 top medtech stories you need to know in late 2017


2. Medical device user fees going up

FDA Trump budget fees medtech innovationU.S. Food and Drug Administration user fees for medical device registrants will increase across the board for the agency’s next fiscal year starting Oct. 1, under the Medical Device User Fee Amendments of 2017 (MDUFA IV) that Congress passed this year.

Standard FDA registration fees for larger companies are going up by a third, with the 510(k) application fee more than doubling, Emergo Group recently reported.

Michael Drues, a regulatory consultant based outside Boston, has warned that MDUFA IV could hinder innovation because it includes new user fees – about $23,000 for small companies and $93,000 for large companies – for requests for de novo device classifications.

“I can think of no better way to stifle or kill innovation than by imposing those kinds of fees, specifically on the de novo,” Drues said in a recent podcast with MDO.

A better solution might be modest fees – perhaps $1,000 – $2,500 – for the hundreds of pre-submission meetings taking place at FDA each year, according to Drues.

Meanwhile, the Trump administration’s proposed federal budget could hurt the speed and quality of FDA review times, according to Glenn Stiegman,  SVP of clinical & regulatory affairs at Musculoskeletal Clinical Regulatory Advisers (MCRA).

In an interesting twist, AdvaMed’s present chairman has floated the question of whether user fees with CMS would help improve the process of achieving Medicare reimbursement for medical devices.

“With MDUFMA, we fought it,” Nadim Yared, president of CVRx, said during this week’s Medtech Conference powered by AdvaMed. “We didn’t want to pay. And it took four iterations and 10 years to get it right.” But, he said, FDA took the resources and used them to create a more inclusive and available FDA.


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