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FDA priority review programme for devices

The US Food and Drug Administration has proposed a new programme under which medical devices would be eligible for a priority review to half the time for premarket approval applications

The US Food and Drug Administration has proposed a new programme under which pioneering medical devices would be eligible for a priority review that would be completed within 150 days, cutting in half the time the federal agency generally takes to review premarket approval applications.

Called the Innovation Pathway, the programme would be reserved for "truly pioneering technologies with the potential of revolutionising patient care or healthcare delivery."

The programme would offer such products a memorandum from the FDA's Center for Devices and Radiological Health (CDRH) containing a proposed roadmap and timeline for device development, clinical assessment and regulatory review.

The products would be assigned a case manager so that key scientific issues would be identified and addressed early in the development process, and some of the devices would qualify for flexible clinical trial protocols.

CDRH is in the process of developing a new oversight body made up of senior managers and scientists who would be responsible for reviewing applications for the programme.

The programme will be open to public comment before it is officially instated, but in the meantime, the FDA has granted a priority review to a brain-controlled, upper-extremity prosthetic as a pilot project. The device, developed by the Defense Advanced Research Projects Agency, uses a microchip implanted on the surface of the brain to restore near-natural arm, hand and finger function to patients with spinal cord injury, stroke or amputation.

The Advanced Medical Technology Association said it was still reviewing the Innovation Pathway proposal but planned to discuss it in detail with the FDA. "We believe it is critical that FDA maintain its focus on bringing greater speed and consistency to the current review process and on addressing the full spectrum of concerns that have contributed to unacceptable delays and inconsistencies," Stephen J Ubl, the group's president and CEO, added in a statement.

The FDA is in the midst of reviewing its 510(k) procedures, which provide fast-tracked reviews for less risky and innovative devices than would be covered by the Innovation Pathway programme.  Under the 510(k) programme, companies can gain marketing clearance by demonstrating that a device is similar to one that is already sold in the US, skipping the need for new clinical trials.

The 510(k) programme has come under fire from industry, which complains that it is administered haphazardly, as well as from politicians and advocacy groups, who argue that it poses safety risks.

9th February 2011

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