Medical Device User Fees Agreement Finally Nearing the Finish Line

Although it has taken longer than it was supposed to, the FDA and medtech industry have reached final agreement on medical device user fees for the next five years under the Medical Device User Fee Amendments (MDUFA) V framework.

Medical Device User Fees

Legislation called the Medical Device User Fee and Modernization Act gives the FDA authority to collect user fees from medical device companies to compensate the agency for performing premarket review for moderate- and high-risk medical devices. Amendments made in 2012 require the agency to pay back industry for this revenue stream by negotiating performance goals designed to make the premarket review process faster and more efficient. The agency also uses the MDUFA framework to set fees for biologics license applications, de novo requests, and 513(g) requests for information.

MDUFA negotiations take place every five years. The latest round, MDUFA V covering years 2023 to 2027, got delayed for a year due to the COVID-19 pandemic. When negotiations finally began, the mood was contentious. Industry entered the talks out for bear given that the FDA failed to meet many of the performance goals set by MDUFA IV to repay the $1.1 billion worth of user fees it collected.

Meanwhile, the clock is ticking. Congress still must pass legislation implementing the agreement the negotiations produce before the current MDUFA IV system expires on Sept. 30. 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 a final MDUFA V deal has apparently been reached. 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 the FDA’s achievement of performance goals.

The agreement includes funding for the FDA’s proposed Total Product Life Cycle (TPLC) Advisory 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 both sides to evaluate the program’s effectiveness.

FDA Reorganizes LDTs Office

On a related note, the FDA recently announced a series of organizational changes within the office that deals directly with new medical devices and laboratory developed tests, the Center for Devices and Radiological Health (CDRH), The changes affect the Office of Product Evaluation and Quality’s Office of In Vitro Diagnostics and Radiological Health, which will be split into two new offices:

• The Office of Health Technology 7, Office of In Vitro Diagnostics (OHT7); and
• The Office of Health Technology 8, Office of Radiological Health (OHT8).

Meanwhile, the Office of Clinical Evidence and Analysis, which is currently made up of two divisions—the Division of Biostatistics and the Division of Clinical Policy and Quality—will be joined by a newly created third division called the Division of Clinical Science and Outreach. The Office of Regulatory Programs is also getting a new fourth division called the Division of Regulatory Systems, Tools, and Data Management.

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Here are some of the key new FDA EUAs and clearances that were announced in late April and May, 2022:

New FDA Emergency Use Authorizations (EUAs) & Approvals

Manufacturer(s)	Product
Hologic	Approval for Aptima CMV Quant assay to quantify viral load of cytomegalovirus in patients who’ve had solid organ or stem cell transplants
BioFire Diagnostics (part of BioMérieux)	De novo approval for Joint Infection (JI) in vitro diagnostic panel
Mirvie	Breakthrough device designation for test to assess woman’s risk of developing preeclampsia before symptoms occur
Fujirebio Diagnostics	De novo approval for Lumipulse G β-Amyloid Ratio (1-42/1-40) test for Alzheimer's disease
Abbott	Approval for Alinity m STI Assay to detect and differentiate between Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium for use on Abbott's Alinity m PCR platform
Audere	EUA for HealthPulse@home Fusion collection kit
LGC Biosearch Technologies	EUA for SARS-CoV-2 ultra-high-throughput End-Point RT-PCR Test
Opti Medical Systems	EUA for Opti SARS-CoV-2/Influenza A/B RT-PCR Test
Quanterix	Breakthrough device designation for blood test to detect relapsing-remitting multiple sclerosis
MicroGem	EUA for MicroGem Sal6830 SARS-CoV-2 Saliva Test
Cleveland Clinic	EUA for SelfCheck Cobas SARS-CoV-2 + Flu Assay PCR test based on Roche's Cobas SARS-CoV-2 & Influenza A/B test