The Subcommittee on Oversight and Investigations today held a hearing titled “Regulatory Reform Series #5 – FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs” to examine the state of the medical device industry and the impact regulations and policies at CDRH have on patient access, innovation, and job creation. The subcommittee addressed the following questions:

  • 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?

“Over the past few years I have personally been aware of many instances where product clearances were denied or significantly delayed by CDRH when the patient benefit clearly outweighed any potential risk to the patient,” said Robert Fischell, MD, and medical device inventor. “The inability for reviewers to be held accountable for their changing standards and increased risk aversion is something Congress must address if we are to improve patient care, promote innovation, and jumpstart our economy.

Fischell said that patients, physicians, innovators, and the public are counting on Congress to restore a “reasonable and predictable CDRH that appropriately balances risks and benefits, works collaboratively with industry, and understands that unnecessarily denying patients access to medical therapies means that FDA is failing in its primary mission, which is to protect patients but also to allow clearance for devices to relieve the pain and suffering that many patients would otherwise have to endure.”

“We at FDA see daily the kinds of problems that occur with medical devices that are poorly designed or manufactured, difficult to use, or are insufficiently tested,” said Jeffrey Shuren, director of CDRH. Shuren urged Congress to allow CDRH to continue to implement the reforms it has in place under the president’s executive order.

In response to the subcommittee’s hearing, AdvaMed’s Ubl said, “While we are concerned with this trend and FDA performance in a number of critical areas, we believe that any steps necessary to address this situation can be taken without changing the current robust statutory standards for clearance and approval of medical devices.”