As of this morning, details of the MDUFMA reauthorization agreementÂ between FDA, Congress, and industry had not yet been released, but AdvaMed president Stephen Ubl shed some light on them at last week's American Institute for Medical and Biological Engineering annual meeting. He shared three points: 1. "We are reducing fees across the board for applications -- whether PMAs or 510(k)s." 2. "The year-to-year increases will be more predictable. There will be no more compensation adjustment, which made the system more volatile." 3. "We estimate that the new goals will bring performance improvements for FDA reviewers and significantly reduce review times." He also noted that "other device trade associations" -- a reference to the Medical Device Manufacturers Association -- support the agreement. This is in contrast to the original act of 2002, which MDMA did not support, and was not involved in the negotiations to craft it. Is this rosy outlook an indicator of a better system on the horizon? We'll see.
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