The Medical Imaging & Technology Alliance (MITA) has applauded the U.S. Senate for its passage of the reauthorization of the Medical Device User Fee Act (MDUFA IV), in a statement posted on its website. The MITA statement is below:
This legislation builds on the progress from the 2012 user fee agreement to further improve the U.S. Food and Drug Administration’s (FDA) device review process while maintaining its robust standards for patient safety.
“The Senate passage of MDUFA is another critical step towards a victory for patients, the industry and the agency,” said Joe Robinson, chairman of the MITA board of directors and senior vice president of health systems solutions at Philips Healthcare. “As the bill moves to the White House for signature, we applaud the bipartisan efforts of the House and Senate to find reasonable, common-sense solutions to clear regulatory hurdles that hinder medical innovation and ensure patient access to life-saving technology.”
The legislation clarifies the FDA’s authority to continue to consider and clear new indications for imaging device manufacturers, while providing contrast agent manufacturers with incentives to update contrast agent labels for products that have previously been approved, which will help spur cutting-edge innovation for patients.
The legislation also calls for the FDA to produce a report on the quality and safety of devices with respect to servicing within 270 days of enactment. Currently, only medical device service activities performed by a manufacturer are regulated by the FDA. If a device fails to perform in a safe and effective manner due to improper servicing by an unregulated, third-party organization, it could potentially put the patient at risk for serious physical injury or result in low image quality – which could lead to a delayed or missed diagnosis.
MDUFA IV, negotiated between the FDA and the medical device industry in 2016, builds on the progress from the 2012 user fee agreement to further improve the agency’s device review process while maintaining its robust standards for patient safety. The latest agreement includes several process improvements that will enhance the predictability, consistency, transparency and timeliness of the premarket review process, including reduction in 510(k) total time to clearance; pre-submission meeting metrics; inclusion of the basis for deficiencies in all deficiency letters and appropriate supervisory review; FDA quality management program and audits; independent assessment; and additional reporting metrics. It will also establish a conformity assessment program for accredited testing laboratories that evaluate medical devices according to certain FDA-recognized standards.