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Consumer Reports Blasts FDA’s 510(K) Medical Device Approval Process

While much of the discussion regarding medical devices often centers on how to speed them to market to create jobs quicker, Consumer Reports is urging that the process be slowed down in the name of safety. Despite the fact that tens of millions of Americans live with medical devices implanted in their bodies, the report states that a large number of these products are never tested before going to market. In fact, under the U.S. Food & Drug Administration’s controversial 510(K) approval process, manufacturers are required to do little more than file paperwork and pay a user fee before marketing the device for use.

Free Medical Device Lawsuit Evaluation: If you or a loved one has been injured by a medical device, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the medical device and we can help.

What’s the problem?

March 28, 2012 – Under 510(K), manufacturers can get clearance to market a product that is ‘substantially equivalent’ in safety and effectiveness to another similar device that is already on the market. Consumer Reports is recommending that Congress force the FDA to require that implants and other critical medical devices be tested at least as rigorously as prescription medications before being allowed to come to market.

The publication is also reportedly in favor of ending the practice of ‘grandfathering’ new medical devices, as well as establishing a ‘unique identifier system’ for implants, so recipients can be promptly and efficiently notified about recalls and other safety problems.

Dr. Robert Hauser, a cardiologist at the Minneapolis Heart Institute and advocate of stricter medical device oversight measures, has stated that he agrees with what Consumer Reports is proposing. “The bottom line is that new devices, particularly [the most complex] lifesaving devices, need to be tested before they are put in people,” Hauser said.

Sen. Amy Klobuchar and Rep. Erik Paulsen, the Congress members leading the effort to revamp 510(K), said it is possible to simultaneously increase efficiency and consumer safety.

“I will continue to work to ensure we have the processes in place to promote safe, pioneering technologies that help save lives, and create good jobs…” said Klobuchar, a Democrat.

Said Republican Paulsen: “Above all else, we must ensure that medical devices are safe — period. I am confident that we can improve the efficiency and effectiveness of the medical device approval process as well as solidify our nation’s position as a global leader in innovation.”

Below are Consumers Report’s recommendations for Congress to improve the safety and effectiveness of devices for consumers.

Improve the pre-market approval process by:

  • Raising standards of approval for devices from “reasonable assurance” of safety to “substantial evidence” of safety to bring it in line with the standard for drugs.
  • Ensuring that implantable and life-sustaining devices do not go through the 510(k) process – requiring them to go through the full pre-market approval process, which requires clinical trials.
  • Removing recalled devices from the list of predicates upon which other devices may seek to be cleared and requiring that devices approved based on a recalled device be automatically reviewed for safety.

Improve current Post-Market Surveillance of devices by:

  • Requiring the FDA to implement a national unique identifier system for devices so that patients and health care providers can be contacted when problems with that device are identified. Currently, there is no universal way to find out which devices went into which patients.
  • Ensuring that the FDA has adequate resources to fully implement existing patient protection programs for monitoring and reporting adverse events such as MedWatch, MAUDE and the Sentinel initiative. Used effectively, these programs can help the FDA identify early and ongoing problems with medical devices that are causing harm to patients.
  • Enabling the FDA to use its recall authority more effectively and providing the FDA with authority to call for longer term post market studies and to require device makers to meet their commitments to conduct post market studies.

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