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The FDA’s Medical Device Issues

By Rheingold Giuffra Ruffo Plotkin & Hellman LLP

Ever since the first approval of medical devices in 1976, the FDA has been struggling to keep up with the pace of technological advancement. Many high-risk devices are approved on the basis of only one clinical trial (compared to new medications, which typically require two trials). On top of that, a small number of clinical studies of these medical devices are even randomised, controlled, and blinded.

Due to these two significant factors, there have been endless warnings and recalls regarding medical devices that were only found to be dangerous after they were on the market. Add to this the problem of the FDA being too large an organisation to devote much attention to a device once it is on the market, it is very likely that many malfunctions remain undetected.

The House of Representatives recently passed legislation, the 21st Century Cures Act, to weaken the FDA’s already-inefficient system of regulation. The new law permits companies that produce high-risk medical devices to submit evidence of safety and efficiency based on sources other than clinical trials-meaning the anecdotes of individual patients can be used rather than scientific studies to demonstrate effectiveness.

The 21st Century Cures Act allows for a faster approval process for ‘breakthrough technologies,’ but on the basis of belief rather than proof. This, in turn, creates a perverse incentive for manufacturers to use the term ‘breakthrough’ loosely, to take advantage of the faster approval process and market to patients in need.

The Act also shifts the burden of proof to clinical studies conducted after the devices have been put into the market. The problem is that many studies of that nature are delayed for months to a year after a device is approved. Many are never completed, and a number that are do not post their findings to the public.

In the event that a medical device is deemed dangerous after its initial approval, it can still prove difficult to remove from the market. For example, in 2006, the Wingspan was quickly approved to prevent recurrent strokes. After a high-quality clinical trial was finally completed in 2011, the intracranial stent was found to actually increase the risk of a patient having another stroke-significantly more so than those patients who did not receive the device. However, despite these findings, the FDA has not withdrawn the device. It narrowed its recommended uses, but the Wingspan continues to be marketed and implanted today, putting patients at unnecessary risk.

The device industry may stand to benefit from this legislation, but the general public does not. Unlike medical drugs, which can be easily discontinued if problems arise, these medical devices are typically implanted permanently, and removal is complicated.

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