Devicemakers: FDA's Performance Not Meeting MDUFMA Commitment
Even though devicemakers are picking up a growing portion of the tab, the FDA is not holding up its end of the bargain — to be interactive, predictable and timely — that it made under the Medical Device User Fee and Modernization Act (MDUFMA). "We're seeing more and more examples where that interactive collaboration ... may be falling short," Mark Leahey, president of the Medical Device Manufacturers Association, said at a MDUFMA reauthorization meeting last week. "As it currently stands right now, I think our members would be hard pressed to support the continuation of this program."
Devices & Diagnostics Letter
Subscribe to:
Post Comments (Atom)

No comments:
Post a Comment