MITA Commends House E&C Committee Efforts to Reauthorize MDUFA and Approve Medical Device Contrast & Servicing Amendments

06.08.17

MITA Commends House E&C Committee Efforts to Reauthorize
MDUFA and Approve Medical Device Contrast & Servicing Amendments

Washington, D.C. – Today the Medical Imaging & Technology Alliance (MITA) commended the U.S. House Committee on Energy and Commerce efforts to finalize the fourth Medical Device User Fee Act (MDUFA IV) in their mark-up of H.R. 2430, the FDA Reauthorization Act (FDARA) of 2017, and approve two important Amendments. The approved Amendments include one filed by Rep. Scott Peters (D-CA) to provide medical imaging device and contrast drug manufacturers a clearer regulatory pathway to ensure patients have access to innovative advanced medical imaging technologies, and another filed by Rep. Ryan Costello (R-PA) to require the U.S. Food and Drug Administration (FDA) to complete their report on servicing of medical devices within 180 days so that Congress can more fully understand how to address issues related to improper servicing.

“MITA applauds the Committee’s efforts to champion reasonable, common-sense solutions to clear regulatory hurdles that hinder medical innovation and ensure consistent regulation of the servicing of medical devices as part of the user fee agreement,” said Joe Robinson, chairman of the MITA board of directors and senior vice president of health systems solutions at Philips Healthcare.

Robinson continued, “Along with our industry partners, we have worked closely with the FDA to develop an agreement that promotes greater transparency and predictability of the device review program, and we look forward to continued collaboration to safeguard timely patient access to safe and effective medical imaging technologies.”

This contrast Amendment will ultimately allow patients in all communities to access the cutting edge innovation in diagnostic imaging by labeling products with new indications for use. It 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 spur even more innovation.

The servicing Amendment will require the FDA to address issues related to improper servicing. 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.

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, measurable and predictable performance goals that support these principles.

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The Medical Imaging & Technology Alliance (MITA), a division of NEMA, is the collective voice of medical imaging equipment and radiopharmaceutical manufacturers, innovators and product developers. It represents companies whose sales comprise more than 90 percent of the global market for advanced medical imaging technology. For more information, visit www.medicalimaging.org. Follow MITA on Twitter @MITAToday.



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