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FDA medical device review times to be subject of House hearing

The House Energy & Commerce Committee’s oversight subcommittee is set to examine the FDA’s performance in clearing medical devices for the U.S. market in a hearing set for this week on Capitol Hill.

On July 20, the GOP-led committee will hold its ’Regulatory Reform Series #5 – FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs’ at 10:30 a.m.

The committee said it will look at the following issues:

  • Have review times for innovative medical devices increased?
  • Has there been a lack of consistency in review and data requirements?
  • Has it become more time-consuming and difficult to get approval for and conduct clinical trials?
  • What has FDA leadership done to improve consistency and transparency in the device approval processes?
  • What do these factors mean for patient access to innovative new devices and treatments?

The witness list includes CDRH director Dr. Jeffrey Shuren, Sean Ianchulev, CMO of Transcend Medical Inc. and Michael Mandel of the Progressive Policy Institute.Mandel recently wrote a piece for the institute highlighting the struggles of the company Mela Sciences (NSDQ:MELA) in obtaining premarket approval for its MelaFind hand-held biopsy device for skin cancer. Mela has been languishing in regulatory purgatory for more than two years in waiting for an answer from the agency.

Mandel’s paper is titled, “Is the FDA Strangling Innovation.”

The subcommittee, which is led by Rep. Cliff Stearns (R-Fla.), is responsible for oversight of agencies, departments and programs within the jurisdiction of the House Energy & Commerce Committee, including the FDA and the Centers for Medicare & Medicaid Services.

 

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