AMDM: FDA Seeking to Double User Fees Under MDUFMA III

Devicemakers could end up paying as much as $600 million in user fees over five years under the Medical Device User Fee and Modernization Act (MDUFMA) III — twice as much as they paid under the last reauthorization. Citing concerns about a possible drop in federal funding, CDRH has said it will need to double the amount of fees it collects to keep the review program running as is, Pat Schrader, vice president of corporate regulatory affairs for Medtronic, said at the Association of Medical Diagnostics Manufacturers (AMDM) annual meeting April 29.
Devices & Diagnostics Letter