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Ingrid Mezo

FDA user fees: Industry pushes for better guidance

September 21, 2010 By Ingrid Mezo Leave a Comment

The Food & Drug Administration’s user fee program collects payments from medical device makers when they submit their devices for review by the federal watchdog agency. Yesterday, MassDevice took a look at competing claims from the medical device industry, the FDA and other stakeholders over the effectiveness of the program. Today we look deeper into whether the program is adequately meeting its own goals.

Another commitment the FDA made in exchange for receiving user fees from industry was to expedite its production of guidance documents to provide industry with a "roadmap" of how to bring a product from development to clearance for sale.

Filed Under: Food & Drug Administration (FDA), News Well Tagged With: Gift Bans

FDA user fees: Faster, more user-friendly guidance needed, industry says

September 21, 2010 By Ingrid Mezo Leave a Comment

The Food & Drug Administration’s user fee program collects payments from medical device makers when they submit their devices for review by the federal watchdog agency. Yesterday, MassDevice took a look at competing claims from the medical device industry, the FDA and other stakeholders over the effectiveness of the program. Today we look deeper into whether the program is adequately meeting its own goals.

Another commitment the FDA made in exchange for receiving user fees from industry was to expedite its production of guidance documents to provide industry with a "roadmap" of how to bring a product from development to clearance for sale.

Filed Under: Food & Drug Administration (FDA), Medical Device Manufacturers Assn. (MDMA), News Well Tagged With: AdvaMed, Gift Bans, Industry Council, Medical Imaging & Technology Alliance (MITA)

Industry troubled by performance trends in FDA user fee program

September 20, 2010 By Ingrid Mezo Leave a Comment

It takes 20 percent longer to obtain a final decision on a 510(k) submission than it did in 2002, despite the millions the Food & Drug Administration has collected from medical device makers in so-called "user fees," according to AdvaMed’s Janet Trunzo.

Trunzo, AdvaMed’s executive vice president for technology and regulatory affairs, was one of several industry association speakers who expressed disappointment in the medical device user fee program at a Sept. 14 workshop held to gain stakeholder input on the program.

"Our companies are concerned that the link between performance and fees has broken down," said Medical Imaging and Technology Alliance executive director David Fisher.

Filed Under: Food & Drug Administration (FDA), Medical Device Manufacturers Assn. (MDMA), News Well Tagged With: AdvaMed, Gift Bans, Industry Council, Medical Imaging & Technology Alliance (MITA)

FDA to examine user fees

August 24, 2010 By Ingrid Mezo Leave a Comment

FDA logo

Medical device companies, whose user fees have funded an increasing share of Food & Drug Administration’s device review budget, will have a chance to weigh in on how well the program is working at a Sept. 14 public workshop.

The federal watchdog agency will offer its own views and solicit input from consumers, patients, healthcare professionals, scientific and academic experts at the meeting, which is scheduled a full two years ahead of the September 2012 expiration date for the current medical device user fee program.

Filed Under: Food & Drug Administration (FDA), News Well Tagged With: Gift Bans

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