New Deal Reached for MDUFA Medical Device User Fees

The U.S. Food and Drug Administration (FDA) and the medical device industry have “reached an agreement in principle” on the next round of medical device user fees under the Medical Device User Fee Amendments (MDUFA V), according to an emailed statement from an FDA spokesperson. "As the agency completes additional steps required in this process, we are meeting daily with industry to negotiate the details of the commitment letter, with a goal of publishing the draft agreement for public comment in the near future, followed by the public meeting and delivering the final recommendations to Congress," the statement added.

The MDUFA Framework

Federal law requires the FDA to perform premarket review for moderate- and high-risk medical devices. In 2002, Congress passed legislation called the Medical Device User Fee and Modernization Act, giving the FDA authority to collect user fees from medical device companies. The Medical Device User Fee Amendments, passed in 2012, not only reauthorized but reformed the MDUFA process. The basic scheme: In exchange for a stream of revenue, the agency must negotiate with the industry to establish performance goals designed to make premarket review faster and more efficient. The agency also uses the MDUFA to set fees for biologics license applications, de novo requests, and 513(g) requests for information. Industry and the FDA negotiate the MDUFA goals every five years. Negotiations for the next round for fiscal years 2023 to 2027, MDUFA V, were slated to start in April 2020 but had to be pushed back due to the COVID-19 pandemic. When negotiations finally did begin early last year, they got off to a contentious start. The fact that the FDA failed to meet many of the MDUFA IV performance goals it accepted in exchange for the $1.1 billion worth of fees it received from industry also did little to improve the mood and trust of the negotiations. Meanwhile, the clock is ticking. Congress still has to pass legislation implementing the agreement the negotiations produce before the current system, MDUFA IV, expires in September. The FDA was supposed to submit a final MDUFA V agreement to Congress by Jan. 15 but missed the deadline.

The MDUFA V Agreement

But now the FDA’s Center for Devices and Radiological Health (CDRH) says that the sides have reached agreement on MDUFA V. While the FDA did not offer details, it has been reported that industry sources familiar with the negotiations have indicated that under the deal, 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 FDA’s achievement of performance goals. The agreement includes funding for the FDA’s proposed total product life cycle program (TAP). TAP would enable the agency to enlist physician advisors, private health insurers, and other outside stakeholders. While expanding agency perspective, such an investment will also significantly increase user fees. After initially opposing the plan, industry has reluctantly agreed to accept it. But there are stipulations. Instead of the full-blown program that the FDA wanted, TAP will be established as a pilot program funded 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 include a mid-point assessment enabling the sides to evaluate the program’s effectiveness. Other key terms of the MDUFA V agreement:

• A three-month cap on the FDA’s use of user fee carryover funds to three months, with additional funds used to reduce sponsor registration fees;
• New FDA hiring targets—the deal: the agency gets extra funding if it hits the targets but industry gets to claw back some of its user fees if the hiring targets are not met; and
• Additional user fee claw back rights in case the FDA fails to meet 510(k), pre-submission, de novo, and premarket approval performance goals, but also providing for additional funding if the goals are met.

Here are some of the key new FDA EUAs and clearances that were announced in February and the first week of March, 2022: 

New FDA Emergency Use Authorizations (EUAs) & Approvals

Manufacturer(s)	Product
Immucor	510(k) clearance for Luminex Lifecodes single antigen Class I and Class II assays
Inspirata	510(k) clearance for Dynamyx digital pathology software, using whole-slide images rather than traditional glass slides for primary diagnosis
AltPep	Breakthrough device designation for blood-based Soba-AD diagnostic test to detect Alzheimer’s disease
Oceanit	EUA for ASSURE-100 rapid COVID-19 test based on saliva spit samples
ChromaCode	Expanded EUA for HDPCR SARS-CoV-2 RT PCR test for use on new qPCR instruments and 384-well plates
Foundation Medicine (Roche subsidiary)	Approval for FoundationOne CDx test as companion diagnostic with Merck's Keytruda (pembrolizumab)
Foundation Medicine (Roche subsidiary)	Breakthrough device designation for FoundationOne Tracker test for circulating tumor DNA detection and molecular monitoring
Datar Cancer Genetics	Breakthrough device designation for TriNetra-Prostate blood test to detect early-stage prostate cancer
Fluidigm	EUA for Advanta Dx COVID-19 EASE Assay PCR-based test
Uh-Oh Labs	EUA for UOL COVID-19 Test