This piece was originally published in the May 2017 issue of electroindustry.
Diane Wurzburger, executive of regulatory affairs at GE Healthcare, testified on behalf of the Medical Imaging & Technology Alliance (MITA) on March 28 at the Medical Device User Fee Act (MDUFA IV) negotiations hearing before the U.S. House of Representatives Committee on Energy and Commerce Subcommittee on Health. She called for swift reauthorization of the user fee program.
“The tentative MDUFA IV agreement advances our shared goals of protecting access to safe and effective medical devices,” she said.
If enacted, the agreement will improve Food and Drug Administration (FDA) review of medical devices, ensuring that American patients have timely access to these technologies.
“MITA supports the FDA in proposing this agreement to Congress and will continue to partner with FDA and other stakeholders in asking Congress to reauthorize this critical program,” Ms. Wurzburger said.
MDUFA IV, negotiated between the FDA and the medical device industry in 2016, builds on the progress from the 2012 user fee agreement to improve the agency’s device review process while maintaining 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, as well as 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.
Reauthorization will also establish a conformity assessment program for accredited testing laboratories that evaluate medical devices according to FDA-recognized standards.
The medical imaging community has long advocated for enhanced predictability, consistency, transparency, and timeliness of the agency’s pre-market approval and clearance process for medical imaging technologies and other devices. MITA and its members believe that all MDUFA commitments should be backed by appropriate, measureable, and predictable performance goals that support these principles.