In an accompanying invited commentary, Rita Redberg, MD, a member of the FDA circulatory System Devices Panel who is affiliated with the University of California San Francisco, says some solutions the FDA has proposed miss the mark. "The FDA's plan places implantable devices, life-sustaining devices and life-supporting devices in the lower-risk category to skirt this critical requirement.
"The FDA is already taking steps to strength its 510(k) review through an internal review, for which it has solicited public comment," she wrote. "Unfortunately, the FDA backed down from several essential safeguards when it released its implementation plan in January 2011. It has asked the Institute of Medicine to perform a review, due in mid-2011."
Zuckerman and co-authors said that correcting the problem "will require either congressional action or major changes in regulatory policy," but that the number of high-risk recalls and the number of patients harmed could be decreased with these four actions:
1. The FDA implements current law that subjects life-saving and life-sustaining devices to the PMA, rather than the 510(k) process.
2. The FDA's definition of a high-risk device takes into account the potential risks if the device fails.
3. The FDA expands the use of their authority to inspect the manufacturing of 5019k) devices just like they do for PMA devices.
4. The FDA strengthens authority to use special controls for 501(k) devices, such as postmarket surveillance, performance standards and product-specific and general guidance documents.