FDA Continues to Look at Re-classifying Numerous Medical Devices

The FDA has spent much of January focused on American medical device issues.  In particular, they have been reviewing the regulatory status of several classes of medical devices already on the market.  The latest segment of the industry to be subjected to FDA scrutiny is the manufacturing of external defibrillators.

External defibrillators have gained a high profile in recent years, as these devices have been installed in office buildings, workout centers, sports arenas and other public areas in order to assist with the resuscitation of victims of heart attacks and other cardiovascular incidents.  Unfortunately, these medical devices, which use electric shocks in order to jumpstart the heart in emergency situations, have also drawn fire from a wide range of critics due to a mounting number of reported malfunctions – 23,000 in total over the past five years, according to an article published by USA Today.  During that same period, 68 defibrillator-related recalls were also initiated by medical device manufacturers.

In the final week of January, the FDA held a meeting to discuss its recommendations for stricter device testing and other safety measures for the defibrillator industryThe Administration has also proposed requiring additional data from defibrillator companies as well as mandatory inspections of manufacturing facilities prior to the release of new models.  This would fundamentally change the current 510(k) premarket approval pathway enjoyed by medical device companies who produce external defibrillators.

Naturally, major players in the defibrillator industry such as Philips Healthcare are against any proposals to move external defibrillators to the same regulatory framework currently used when handling the market approval of implantable defibrillators and other cardiovascular medical devices.  A key argument is that 500 people are saved every year thanks to the distribution of public defibrillators, a practice that could be threatened should the costs of devices increase due to additional evidence and inspection requirements.

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republished and adapted with permission from the MDCI

[editor’s note: see all 79,000+ adverse events reported to the FDA related to defibrillators here.]

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