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FDA Proposes StreamLined Pathway for New Medical Device Approval

The U.S. Food and Drug Administration proposed a new program, the Innovation Pathway, to streamline approval of new medical devices. While the program could help patients by getting new, innovative devices to the market sooner, the expedited review process could allow medical device defects to go unnoticed, potentially harming consumers.

The Innovation Pathway Program

The FDA's Center for Devices and Radiological Health announced the program in February, 2011, and is taking public comment before the Innovation Pathway is applied to advance a variety of products to the marketplace.

According to the FDA, the Innovation Pathway would make the following changes to improve medical device safety in the product development process:

  • Establish a voluntary, third-party certification program for medical-device test centers to promote product improvement during the development and clinical testing stages
  • Make a standard curriculum for medical device development and testing publicly available
  • Collect data and information on device use from outside the U.S.

To qualify for the Innovation Pathway program, the FDA stated that medical devices must be “truly pioneering technologies with the potential of revolutionizing patient care or health care delivery.” Once accepted the products would be reviewed by senior managers and scientists within the CDRH throughout the design and testing process.

The program aims to cut the review period for innovative products from the current 10 months down to five months. Medical device producers say that a faster review process is necessary to compete with world markets and to help patients get life-changing medical devices without unreasonable or unnecessary delay.

The CDRH and an agency of the U.S. Department of Defense have agreed to pilot the Innovation Pathway program on a prosthetic arm that would remotely link to a microchip implanted in the brain, decoding signals from neurons and allowing the wearer almost natural control over the arm, hand and fingers.

The FDA-Approval Process

The FDA has come under fire for its approval of medical devices that have later been recalled for product defects. A recent report by the Government Accountability Office criticized the FDA for its handling of high-risk medical devices and consumer health advocates claim the FDA is too quick to approve these products, such as the DePuy artificial hip implants made by Johnson & Johnson that are the cause of major issues for those who've received the implant.

The FDA currently has two procedures for approving new medical devices. One is premarket approval, which is the most rigorous review of new, high risk medical devices. The other is a less stringent review called 510(k) premarket notification.

If a medical device producer can demonstrate that its product is substantially equivalent to an existing device already on the market, the product can bypass the traditional premarket approval process and go through 510(k) premarket notification. Unlike the premarket approval process, clinical testing on human patients is not required in the 510(k) review process.

The 510(k) process is normally reserved for low-risk devices, but the GAO report revealed that, between 2005 and January 2009, the FDA approved at least 67 high-risk medical devices through the 510(k) process. In fact, the Johnson & Johnson DePuy artificial hip implant was one of the high risk products approved through the 510(k) process without human clinical testing. Later studies found that one in eight of the Johnson & Johnson artificial hip implants had to be replaced, and 90,000 implants were eventually recalled.

There were 3,510 voluntary recalls of medical devices from 2005 to January 2009, which amounts to about 700 recalls each year. Yet, the FDA “has not been routinely analyzing recall data that would allow it to explain trends in recalls over time, thus missing an opportunity to proactively identify and address the risks presented by unsafe devices,” reported the GAO.

The GAO report also stated that the FDA is evaluating whether some high risk medical devices should be tested more thoroughly, but it continues to approve high-risk devices under current standards, putting patients at risk of harm from medical devices with latent defects.

As demonstrated by the Johnson & Johnson hip implant debacle, patients suffer harm when new medical devices are not adequately tested. The FDA's proposed Innovation Pathway program could help bring medical devices to patients-in-need faster, but it is imperative that those devices are proven safe through proper testing and review.

If you have been harmed by a defective medical device, contact an attorney with experience in product liability cases to discuss your legal options and any right to compensation you may have.

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