FDA Demands Info on Older Medical Devices

David Mittleman

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Earlier this week, the Food and Drug Administration (FDA) requested information on decades-old medical devices marketed by companies such as Medtronic. These devices, which range from wheelchairs to pacemakers, hit the market prior to 1976 – the year the FDA was first authorized to review and approve medical devices. According to an article by the Wall Street Journal, these medical products were allowed to remain on the market after only a cursory review of their safety.

One major concern is that high-risk devices such as pacemakers – known as Class III devices – might not be as safe and effective as previously believed. Due to what is essentially a loophole in the approval process, the FDA has approved Class III products without the stringent testing now required of new devices.

Medical device companies have 120 days to comply with the request for information. Medtronic claims that its devices are safe and that they have some thirty years’ worth of evidence to back up their assertion.