The U.S. House of Representatives passed the reauthorization of the Medical Device User Fee Act (MDUFA IV) on July 12, legislation providing new indications for imaging device manufacturers.
Without the bill being signed into law, the FDA’s authority to collect user fees from companies it regulates would expire at the end of September. The agency has warned that unless its enacted by the end of July, it would need to lay off thousands of FDA employees. The bill had enough support in the House to pass by voice vote.
The move was welcomed by the Medical Imaging & Technology Alliance (MITA), which supported the FDA’s continued authority on new indications for imaging device manufacturers and the provision requiring a report on quality and safety of devices.
“MITA is encouraged by the reauthorization of MDUFA by the House and sees the user fee agreement as a win for patients, the industry and the agency,” said Joe Robinson, chairman of the MITA board of directors and senior vice president of health systems solutions at Philips Healthcare. “We are hopeful that the momentum of this legislation in Congress will take it over the finish line in the Senate and that it will be signed into law in short order.”