This piece was originally published in the October 2017 issue of electroindustry.
Megan A. Hayes, Director, Regulatory and Standards Strategy, MITA
In August 2017, Congress passed the Food & Drug Administration Reauthorization Act of 2017 (FDARA), which reauthorizes various FDA user fee programs, including the Medical Device User Fee Amendments (MDUFA). This fourth reauthorization of MDUFA builds on the progress from the 2012 user fee agreement to further improve the FDA’s device review process while maintaining its robust standards for patient safety.
MDUFA IV, negotiated between the FDA and the medical device industry in 2016, 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 FDA-recognized standards.
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 because of improper servicing by an unregulated, third-party organization, it could potentially put the patient at risk for injury or result in a delayed or missed diagnosis.
FDARA is a win for all stakeholders: the FDA receives necessary funding, industry benefits from various programs and reduced time to decision, and patients have timely access to safe and effective medical devices.