The FDA missed a deadline to submit a new agreement on user fees for medical device makers in order to speed up product reviews, according to a Bloomberg Businessweek report.
The 2007 law set the user fee at $295 million over five years to speed up the device approval process. The law is set to be reauthorized this year and requires a new agreement be submitted for congressional approval by Jan. 15. A U.S. House hearing is scheduled for Feb. 15, and if the FDA and medical device companies can't reach an agreement by then, Congress could take over the negotiations.
The FDA wants to increase the user fees to $730-$805 million over five years, but the medical device industry has said it will only pay $447 million. The fees would go toward hiring additional staff. The agency estimated it would need 225-321 new employees to conduct reviews, according to Nov. 29 meeting minutes.
Review times have decreased since the user fees were implemented. In 2010, the FDA took an average of 73 day to complete 510(k) reviews, which apply to more than 90 percent of devices. In 2001, 510(k) reviews took an average of 80 days, according to a Bloomberg Government study.
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The 2007 law set the user fee at $295 million over five years to speed up the device approval process. The law is set to be reauthorized this year and requires a new agreement be submitted for congressional approval by Jan. 15. A U.S. House hearing is scheduled for Feb. 15, and if the FDA and medical device companies can't reach an agreement by then, Congress could take over the negotiations.
The FDA wants to increase the user fees to $730-$805 million over five years, but the medical device industry has said it will only pay $447 million. The fees would go toward hiring additional staff. The agency estimated it would need 225-321 new employees to conduct reviews, according to Nov. 29 meeting minutes.
Review times have decreased since the user fees were implemented. In 2010, the FDA took an average of 73 day to complete 510(k) reviews, which apply to more than 90 percent of devices. In 2001, 510(k) reviews took an average of 80 days, according to a Bloomberg Government study.
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Open Source Robotic Surgery to be Researched at US Universities
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Samsung Open to Partnering with Olympus on Medical Devices