Between 2005 and 2009, 113 devices were recalled because the FDA determined those devices could cause serious health problems or death. Most medical devices recently recalled by the Food and Drug Administration because of very serious risks, were initially approved through an expedited process or were exempt from regulatory review.
A study to be released in upcoming months states:
“Unlike prescription drugs, medical devices are reviewed by the U.S. Food and Drug Administration (FDA) using two alternative regulatory standards: (1) premarket approval, which requires clinical testing and inspections; or (2) the 510(k) process, which requires that the device be similar to a device already marketed (predicate device). The second standard is intended for devices that the FDA deems to involve low or moderate risk.”
Out of all the recalled devices over the four year period, 19% had been approved through the premarket approval process, 71% through the 510(k) process and 7% were exempt from regulation.
The report continues:
“Of the recalled devices cleared for market through the 510(k) process, 12% were marketed for risky or life-sustaining Class III indications, which are required by law to undergo a full premarket approval regulatory review. The FDA’s implementation of the 510(k) process has received considerable criticism from public health advocates and from other federal agencies in reports, medical journal articles and testimony before Congress.”
The high-risk recalls included devices with a broad range of clinical applications, but the most common were cardiovascular devices (31%). Of these, two-thirds (23, or 66%) were approved using the expedited 510(k) process and 12 (34%) were cleared through the post market approval process.
The federal court system also recognized the shortcomings of the expedited process. However, the relatively small division of the FDA charged with device approvals does not receive sufficient funding from Congress to conduct premarket approval on every device, the authors note.
In conclusion:
“When devices that were intentionally exempt from any FDA review were added to the 510(k) devices, they comprise more than three out of four of the high-risk recalls during the last five years. Thus, the standards used to determine whether a medical device is a high-risk or life-sustaining medical product prior to approval are clearly very different from the standards used to recall a medical device as life threatening. Our findings reveal critical flaws in the current FDA device review system and its implementation that will require either congressional action or major changes in regulatory policy.”
Last week the FDA this week has proposed a new Innovation Pathway program that will enable the approval process of new groundbreaking technologies be expedited more rapidly and delivered to the public for use in the field. The first submission is a brain-controlled, upper-extremity prosthetic. The program seeks to quickly identify and nurture technology that has the potential to transform medical care and the way it is delivered to patients.
Officials hope the expedited review will cut in half the time it takes to approve or reject a device. Devices accepted for speedy review must still meet all safety standards.
To be considered for this priority approval channel products would have to be truly pioneering technologies with the potential of revolutionizing patient care or health care delivery. Then, selected products would receive an Innovation Pathway 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.
Finally, products would be assigned a case manager, their important scientific issues would be identified and addressed earlier in the development process, and they might be able to qualify for flexible clinical trial protocols.
Full Report:
Written by Sy Kraft, B.A.