US House passes medical device user fee agreement

The US House of Representatives today passed a bill to reauthorize the FDA’s medical device user fee program, alongside a prescription drug, generic drug and bio similar programs through 2022. Newly appointed FDA commissioner Scott Gottlieb applauded the passage, saying it was a “timely reauthorization key for FDA, patients,” on Twitter after the bill passed. “This legislation will save lives,” Rep. Greg Walden (R-OR) said on the house floor, according to a Regulatory Affairs Professionals report on the vote. The Senate has not yet scheduled a floor debate for its version of the user fee bill, but is likely to consider them in the immediate future. The Medical Imaging & Technology Alliance and the Medical Device Manufacturer’s Association both lauded the bill’s passage. “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. 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,” MITA chair & Philips senior VP of health systems Joe Robinson said in a press release. “MDMA applauds the overwhelming bipartisan support for MDUFA reauthorization which will provide for more predictability and transparency in the FDA’s regulatory pathways. The numerous policies contained in this legislation will empower medical technology inno...
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Wall Street Beat Capitol Hill User fees Source Type: news