House Energy & Commerce Health Subcommittee Holds Hearing on MDUFA

On Tuesday, the House Energy & Commerce Health Subcommittee held a hearing titled “Examining FDA’s Medical Device User Fee Program” which addressed the vital role of the Medical Device User Fee Agreement (MDUFA) in enabling the FDA to review new medical devices and software in a safe and timely manner. The hearing focused on the latest iteration of MDUFA – MDUFA IV - which seeks to build on past agreements by continuing to decrease review times, improve quality and increase patient access to innovative medical devices.

MDUFA IV needs be authorized by Congress by the end of July to prevent a delay in device reviews and layoff notices being issued to FDA employees. In his opening statement, Chairman Burgess (R-TX) touted the success of MDUFA and affirmed the Committee’s commitment to reauthorizing the agreement by  stating “reauthorizing MDUFA and the user fee programs we have previously discussed would increase efficiency at FDA and ensure that American patients benefit from advances in biomedical technology and innovation as soon as safely possible.”

The hearing featured two panels of witnesses, the first including Dr. Jeffery Shuren, Director of the FDA Center for Devices and Radiological Health (CDRH), who provided testimony on the success of MFUDA and improvements that would be made under the MDUFA IV agreement. During his testimony, Dr. Shuren emphasized how MDUFA IV will help “establish a digital health unit” within the CDRH. Dr. Shuren also highlighted how the new agreement would support the development of the National Evaluation System for Health Technology (NEST), allowing the FDA to “harness real world data collected during routine care, lowering the cost of new devices coming to market.”