The White House has put its John Hancock on an agreement between the FDA and the medical device industry, bringing MDUFMA III—the latest iteration of the Medical Device User Fee & Modernization Act—a leap closer to liftoff.
The Office of Management & Budget’s green light comes one month after Consumers Union warned Congress that reauthorizing MDUFMA could lead to a significant increase in the number of unsafe medical devices entering the market.
MDUFMA III calls for device makers to double the fees they pay FDA in exchange for speedier and more predictable reviews.
“At a time when the device industry has seen large-scale safety failures of some of its products, it is troubling that the main focus of conversations between industry and the agency that regulates it is on speeding up review times,” said Lisa Swirsky of Consumers Union at the February hearing.
The next step will be a March 28 public workshop at which interested parties will be invited to speak their piece to FDA on the draft recommendations. “We welcome this opportunity to hear from stakeholders as we conclude negotiations for the next reauthorization of the medical device user fee program,” said FDA in its meeting announcement.
The FDA will then publish the agreement in the Federal Register for a 30-day public comment period and make final revisions before presenting the package to Congress for full legislative review—and, likely, considerable wrangling.