Sen. John Kerry is jumping into the debate over the way medical devices are cleared for the U.S. market.
Kerry, D-Mass., wrote an open letter to FDA chief Dr. Margaret Hamburg, relaying concerns he’s heard from constituents in the Bay State’s medical device industry that changes to the 510(k) pre-market notification process could be “unnecessarily burdensome and delay life-saving technology from coming to market.”
Kerry specifically highlighted several of the medical device industry’s key beefs with the proposed changes to the system by which a majority of medical devices come to market, including a new Class IIb designation. The senator also said he’s concerned that there’s no industry representation on the Institute of Medicine’s review panel, which has been tasked with independently reviewing the 510(k) program.
The IOM completed its review of the clearance protocol and is moving into a peer review phase of its study. Adding some med-tech voices to the panel could help quell persistent complaints that the medical device industry has been woefully under-represented in the FDA’s 510(k) reform process.
Kerry asked the FDA chief to “establish a deliberative and transparent process for reviewing the IOM recommendations that ensures adequate opportunity to solicit substantive and meaningful input from all stakeholder groups.”
He also reiterated his commitment to patient safety, calling it his “highest priority.”
The senator’s letter adds to a slew of activity going on in Washington, D.C., over changes afoot in the medical device industry. A Senate Special Committee on Aging is holding hearings on the FDA’s medical device approval process.