MDUFMA FY 2007 User Fees ReleasedMDUFMA FY 2007 User Fees Released
FDA has released the FY 2007 user fee structure as per MDUFMA and MDUFSA. The PMA fee will increase to $281,600, a jump of almost 8.5%, the maximum allowed under MDUFSA. The 510(k) fee increases at a similar pace, to $4,158. For small businesses, defined as those with under $100 million in revenues, the PMA fee is $107,008 and the 510(k) fee is $3,326. The new rates take effect October 1. Firms with under $30 million in revenues continue to qualify for a waiver of the first PMA. MDUFSA made fees less burdensome to industry.
August 3, 2006
The question now is whether the program is giving FDA the resources it needs to do its job. Let's hope that's hashed out properly in discussions for reauthorization, which needs to happen by October of 2007.
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