Focusing on Regulatory Environment

Focusing on Regulatory Environment

This piece was originally published in the November 2016 issue of electroindustry.

Diane Wurzburger, Executive, Regulatory Affairs, GE Healthcare

MITA’s Technical and Regulatory Committee (TRC) promotes a regulatory environment that supports growth and innovation in medical imaging.

In 2016, the TRC set three priorities: successful Medical Device User Fee Amendments (MDUFA) negotiations; critical to quality (CtQ) engagement, which is part of a of the U.S. Food and Drug Administration (FDA) initiative related to medical device quality; and resolving the contrast issue, a long-standing MITA project to create a reasonable regulatory pathway for clearance of medical devices with contrast agents.

The TRC works with the FDA on key issues related to medical imaging technology and supporting other MITA sections and committees in their regulatory efforts.


When MDUFA IV negotiations began in September 2015, MITA’s goals were to improve timeliness, consistency, and predictability throughout the premarket review process. The team advocated for improved performance in exchange for increased resources. The resulting agreement expands these performance metrics:

  • Reduction in total time to 108 days for 510(k) decisions, which demonstrate that a device is at least as safe and effective as one that is not subject to premarket approval
  • More rigorous scheduling and feedback goals for pre-submission meetings
  • Traceability of all reviewer questions and requests for additional information to regulation, guidance, standards, or relevant scientific evidence
  • New quality management targets and standards conformity assessment
  • Quarterly summary medical device reporting

 CtQ Engagement

Since 2011, the FDA collaborates with stakeholders on defining activities and characteristics that drive product and manufacturing quality. The goal is to focus attention on attributes and data that promote the practice and culture of quality within firms—as opposed to compliance with regulations alone—and thereby increase the quality of devices.

Knowing what device attributes are critical to device quality allows product development teams—and ultimately manufacturing teams—to ensure the right focus is on items that are most critical to safe and effective performance. MITA is considering whether there are issues for medical imaging technology that could be addressed, such as whether there are any high level issues (e.g., x-ray emissions) that might be appropriate to document.


The current FDA regulatory pathway for premarket clearance of imaging device indications that may be used with contrast agents is complicated, forcing device manufacturers to navigate a process that may include multiple FDA centers. The TRC is dedicated to a streamlined and timely pathway-to-market that allows imaging applications and contrast agents to keep pace with innovative performance and standards of care. MITA collaborated with the Council on Radionuclides and Radiopharmaceuticals, the contrast agent trade association, to develop a legislative framework for clearance of medical imaging devices involving the use of contrast agents.

FDA Interaction

MITA sections and committees seek opportunities with FDA leadership and staff that will establish it as a valuable stakeholder for discussions regarding medical device policy, including:

  • influencing the agency’s priorities, policy positions, and regulatory pathways
  • collaborations with other associations to develop consensus on challenging policy issues that impact market access of medical imaging devices
  • comment letters on relevant FDA Federal Register notices, draft guidance documents, and public meeting dockets

These interactions are strategically planned to influence the development and implementation of regulatory priorities and policies that are aligned with MITA goals and support growth of the diagnostic imaging market as well as continued patient access.

Read the November 2016 issue of electroindustry.

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