Two industry groups have announced their support for HR 2009, the Fostering Innovation in Medical Imaging Act of 2017, introduced by Reps. Ryan Costello (R-PA) and Scott Peters (D-CA).
The bipartisan bill provides medical imaging device and contrast drug manufacturers a regulatory pathway to ensure patients have access to advanced medical imaging technologies, said the Medical Imaging and Technology Alliance (MITA) and the Council on Radionuclides and Radiopharmaceuticals (CORAR).
Many of new medical imaging technologies are indicated with previously approved contrast agents. In some instances, medical imaging technology advances have outpaced the approved contrast agent labels, according to the groups. This bill builds on the 2017 user fee agreements and will ultimately allow patients to access innovation in diagnostic imaging by labeling products with new indications for use. The bill clarifies the U.S. Food and Drug Administration's (FDA) 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 were previously approved under FDA's safety and efficacy standard.
By clarifying the process for imaging equipment manufacturers to gain approval for new technologies that use formerly approved contrast agents, this bill will spur even more innovation, MITA and CORAR said.
