The Medical Imaging & Technology Alliance is urging swift Congressional passage of the fifth iteration of the Medical Device User Fee Agreement (MDUFA V) as drafted.
“Through over a year and a half of negotiations, we have agreed to a good deal for the FDA, industry, and most importantly for patients,” says Patrick Hope, MITA’s executive director, regarding MDUFA V. “The agreement will help get the FDA back on track after several years of grappling with the COVID pandemic and introduces new accountability measures related to hiring targets, accrual and use of carryover balance.”
Under the agreement, the FDA will receive $1.784 billion in user fees over the next five years, but that number could go up to $1.9 billion if the agency meets certain performance goals. The agreement also includes a targeted Total Product Lifecycle Advisor Program (TAP) pilot project that scales up over five years, facilitating early, rapid interaction between FDA and industry on novel innovative products.
The TAP pilot program will also include a mid-point assessment that will allow the FDA and industry to evaluate the program’s effectiveness.
“We encourage Congress to act swiftly to pass this agreement and we look forward to working with the Center for Devices and Radiological Health on meeting its commitments under this agreement and implementation of the TAP pilot project to enhance communication, collaboration and engagement between the agency and medical device stakeholders,” Hope says.