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Home 5 Articles 5 FDA and Industry Reach Agreement on MDUFA V Medical Device User Fees

FDA and Industry Reach Agreement on MDUFA V Medical Device User Fees

by | Mar 14, 2022 | Articles, News, Open Content

For a while, it looked like the FDA and medical tech industry might not cut a deal on the next round of medical device user fees under the Medical Device User Fee Amendments (MDUFA V) before the current agreement expires in September. But last week, the agency announced that the sides had reached “an agreement in principle.” While the FDA didn’t offer details, reports cite industry sources familiar with the negotiations as saying the agency will receive a minimum of $1.78 billion in user fees from 2023 to 2027, which could increase to $1.9 billion based on the FDA’s achievement of hiring targets and performance goals related to 510(k), pre-submission, de novo, and premarket approval. If goals aren’t met, industry will be able to claw back a portion of previously paid user fees. Despite initial industry opposition, the agreement also includes funding for the FDA’s total product life cycle program (TAP). But rather than a full program, it’ll be a pilot program financed by $110 million in funding left over from MDUFA IV and $45 million from agency base funding. At industry’s insistence, the TAP pilot will also provide for mid-point assessment of the program’s effectiveness.

A photo illustration of a hand reaching out to various medical-related icons to represent medical technology

For a while, it looked like the FDA and medical tech industry might not cut a deal on the next round of medical device user fees under the Medical Device User Fee Amendments (MDUFA V) before the current agreement expires in September. But last week, the agency announced that the sides had reached “an agreement in principle.”

While the FDA didn’t offer details, reports cite industry sources familiar with the negotiations as saying the agency will receive a minimum of $1.78 billion in user fees from 2023 to 2027, which could increase to $1.9 billion based on the FDA’s achievement of hiring targets and performance goals related to 510(k), pre-submission, de novo, and premarket approval. If goals aren’t met, industry will be able to claw back a portion of previously paid user fees.

Despite initial industry opposition, the agreement also includes funding for the FDA’s total product life cycle program (TAP). But rather than a full program, it’ll be a pilot program financed by $110 million in funding left over from MDUFA IV and $45 million from agency base funding. At industry’s insistence, the TAP pilot will also provide for mid-point assessment of the program’s effectiveness.