House Republicans will finally get their chance to grill CDRH chief Dr. Jeffrey Shuren about the FDA’s “inconsistent application of reasonable standards for safety” in clearing medical devices for the U.S. market.
The House Oversight & Government Reform Subcommittee on Health Care is slated to hold its “Pathway to FDA Medical Device Approval: Is there a Better Way?” hearing June 2 to “study the FDA’s inconsistent application of reasonable standards for safety and effectiveness in approving medical devices, and the impact it has on American job creators.”
The hearing, originally on tap in April, was abruptly canceled shortly before it was due to start because of time constraints, one of the committee’s aides told MassDevice at the time.
The GOP-led panel is set to call Rep. Erik Paulsen (R-Minn.); Shuren; Jack Lasersohn, a general partner at venture capital firm The Vertical Group; David Gollaher, president and CEO of the California Healthcare Institute; and Dr. Rita Redberg, director women’s cardiovascular services in the division of cardiology at the University of Calif., San Francisco. The committee is chaired by Rep. Trey Gowdy (R-S.C.).
The subcommittee is likely to encounter a friendly witness in Eden Prairie, Minn.-based Paulsen, who recently pledged to push legislation to modernize and streamline FDA processes. Co-chairman of the House Medical Technology Caucus, Paulsen gave the keynote address to the Advanced Medical Technology Assn.’s annual conference in Washington, D.C., last year.
High on Paulsen’s priorities are the development of an “Innovation Pathway” for pioneering medical devices and blocking a proposed $20 billion tax on the medical device industry.
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