510(k) reform: Covidien’s Almeida says IOM report didn’t deliver on objectives

Joe Almeida

Covidien CEO Joe Almeida at the MassDevice Big 100 Regional Roundtable, July 11, 2011

The new CEO for Covidien Plc. (NYSE:COV) took the recently released study of the FDA’s 510(k) program to task this morning, saying the institute failed to deliver on what it was tasked with doing when hired by the FDA nearly two years ago.

“It you read what the FDA had commissioned the IOM to deliver, it did not [meet the objectives],” Jose Almeida told MassDevice. “It’s a little disappointing that the IOM was not able to answer the questions for the FDA and I think the FDA is as much disappointed with the results as we were.”

Listen to our recent interview with Covidien CEO Joe Almeida

Last week, the independent IOM released its 22-month review of the 510(k) premarket review process, commissioned in 2009 by the FDA’s Center for Devices & Radiological Health. The report is not binding on the agency but it has created a stir within medical device circles as it called for the scrapping of the 510(k) process altogether and starting over with an “integrated pre-market and post-market regulatory framework.”

The reaction from the medical device industry was swift and condemnatory.

“The report’s conclusions do not deserve serious consideration from the Congress or the Administration,” said Stephen Ubl, president and CEO of the Advanced Medical Technology Assn., in a prepared release after the report was released.

Almeida, a member of AdvaMed’s board of directors and the chairman of the industry council’s 2012 conference executive committee was more measured in his response to the IOM’s recommendation.

“For us the objective is to make sure patient safety is the first and foremost important thing and we’re going to work with the FDA to create mechanisms to make the 510(k) and PMA programs more straightforward,” he told us. “But it is always with patient safety in mind.”

And while some have suggested that the IOM report could have an impact on the negotiations over the reauthorization of the Medical Device User Fee and Modernization Act fees, Almeida disagreed, calling them two separate issues that shouldn’t be jumbled up together.

“The reauthorization of the user fees that we’re dealing with the FDA are about effectiveness, efficiency and productivity of the system and has nothing to do with that,” he said.

The FDA has said it is planning a public meeting on the controversial recommendations made by the IOM for this fall.

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