ACC Chief Medical Officer and former President Richard Kovacs, MD, MACC, on March 30 testified on the reauthorization of the U.S. Food and Drug Administration (FDA) Medical Device User Fee Act (MDUFA) program in a hearing before the House Committee on Energy and Commerce Subcommittee on Health. The hearing also addressed two proposed bills: the Protecting and Transforming Cyber Health Care (PATCH) Act of 2022 (H.R. 7084) and the Diagnostic Device Advisory Committee Act (H.R. 7192).

Originally signed into law in 2002, MDUFA is a set of user fee agreements between FDA and the medical device industry for the agency's review of medical devices. The act must be reauthorized every five years. MDUFA IV, the current authorization, will expire Sept. 30, and the new MDUFA V will need to pass to reauthorize the legislation.

In his testimony, Kovacs noted that MDUFA V appears to build on FDA's commitment for "identification of novel methods of obtaining data that may prove or disprove safety and efficacy" and focused his comments on the "importance of the patient voice within the device development process, regulating the total product life cycle, utilizing real-world evidence throughout, and the ongoing development of regulatory science."

Kovacs noted the role of MDUVA IV in recognizing the "important role external stakeholders play in the device development process" but encouraged that the reauthorization "include additional opportunities for patient input." He cited ACC's efforts to include patient-reported outcomes in the NCDR clinical data registries. Specifically, he noted the need to expand capacity to address patient preferences and improve ability to collect patient-generated information remotely. He also called for guidance on best practices to incorporate clinical outcomes assessments in pre-market studies and the use of patient input to inform clinical trials and reduce barriers to clinical trial participation, including the recruitment and retention of diverse populations.

In addition, Kovacs mentioned the need for data collection in both pre- and post-market research to ensure efficacy and safety and the role of real-world evidence in improving outcomes, particularly for populations that have been historically underrepresented in clinical trials.

Regarding proposed legislation, Kovacs noted the College's support for inclusion of the PATCH Act, which would implement cybersecurity protocols for manufactures applying for pre-market approval through the FDA, and Diagnostic Device Advisory Committee Act, which would create an advisory committee specifically for diagnostic devices, in the MDUFA reauthorization.

Kovacs closed by thanking the FDA, medical device manufacturers and other stakeholders "for coming together and putting forth a framework that aims to better the lives of the patients we serve." "We constantly strive to improve and refine our efforts to better achieve our mission of transforming cardiovascular care and improving heart health," he said. "The ACC looks forward to working with the members of this committee on the passage of the essential legislation required to implement future agreements and other important issues that are so vital to patient access and care."

Clinical Topics: Cardiovascular Care Team

Keywords: United States Food and Drug Administration, Advisory Committees, Registries, Patient Reported Outcome Measures, Outcome Assessment, Health Care, Data Collection, Computer Security, Life Cycle Stages, ACC Advocacy

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