The 3rd iteration of the FDA’s medical device user fee program rolls ever closer to finalization, as the watchdog agency and industry players move forward with a draft of the legislative language.
In a back-to-back series of 5 meetings in the first half of February, the FDA and med-tech leaders closed up some exceptions to the requirements of the Medical Device User Fee & Modernization Act, hashed out a new structure for inflation adjustments and reconciled a discretionary fee waiver for laboratory-developed tests.