MITA applauds FDA for recently finalized guidance on the Safer Technologies Program (STeP) for medical devices

January 18, 2021
Washington, D.C. – The Medical Imaging & Technology Alliance (MITA), the leading organization and collective voice of medical imaging and radiopharmaceutical manufacturers, innovators, and product developers, today announced its support for the Food and Drug Administration's (FDA) recently released program guidance, Safer Technologies Program (STeP) for Medical Devices, Guidance for Industry and Food and Drug Administration Staff. The final guidance will allow timelier access and expedited approval for novel medical devices and imaging modalities.

“The finalized guidance program broadens the scope of medical products that may now be eligible for fast-tracked approval,” said Patrick Hope, Executive Director of MITA. “This is a significant step for the FDA in recognizing that medical products, including medical imaging modalities, treat a variety of diseases – and those that don’t meet the ‘Breakthrough’ designation criteria are still important innovations that can positively support American patients.”

The guidance outlines the voluntary, expedited review program for medical devices and device-led combination products which may significantly improve the safety and performance of currently available treatments for morbidities not eligible for the Breakthrough Devices Program. SteP is a complementary program intended to bring innovative medical devices and procedures to patients faster.

“MITA hopes to see these trends of supporting innovation, increased transparency and communication between the FDA and manufacturers continue long into the future,” Hope added.