by
Lisa Chamoff, Contributing Reporter | May 12, 2014
From the May 2014 issue of HealthCare Business News magazine
The current 510(k) application costs about $5,000. By contrast, the proposed PMA application costs more than $250,000. There’s also a difference between ongoing maintenance of PMA-approved devices compared to a 510(k) approved device. Design changes under the 510(k) regulations often don’t require a new submission, but under the PMA process, FDA approval will be required for more design changes and also manufacturing changes that a company makes to a product.
Manufacturers have asked the agency to reclassify AEDs under Class II with “special controls,” including testing to industry standards, certain labeling and guidance documents and post market surveillance.
Other consumer and patient safety advocacy groups have long called for AEDs to be held up to a higher regulatory standard after the recall of hundreds of thousands of defective or potentially malfunctioning devices over the past decade.
Dr. Michael Carome, with Public Citizen, a watchdog group that has argued for the reclassification of the devices, says he think it’s a “flawed argument” that innovation will be stifled by more stringent regulations.
“We think, to ensure patient safety, that a PMA process is reasonable,” Carome says. “I think they’ll have to demonstrate and meet a higher threshold to make sure the quality of the devices are safe and effective.”
Device malfunctions: On the upswing, or hyped up?
Late last year, the FDA issued a safety communication on the Heart- Start AEDs manufactured by Philips Healthcare. In September 2012, Philips initiated a voluntary recall of approximately 700,000 devices after determining that an internal electrical component could fail, and the device could incorrectly indicate it is ready for use. The December 2013 safety communication included recommendations to better inspect and monitor the readiness of the devices, advising owners to contact Philips if the AED emits a triple chirp and has a flashing “i-button” during self-testing, which means a problem that could prevent the device from delivering an electrical shock has been detected.
In the recent safety communication, the FDA also noted that it classified Philips’ September 2012 recall of the HeartStart AEDs as a Class II recall “after determining that the chance of serious adverse consequences or death due the device failure is remote. In this current situation, the FDA believes that because the patients who need these devices are in a life threatening situation, the chance of serious adverse consequences or death directly related to AED failure is very difficult to conclusively determine.”
