FDA Plans to Overhaul and Update the Long-Criticized Medical Device Approval Process

The United States Food and Drug Administration has finally announced their plan to overhaul the most common avenue for medical device manufacturers to bring their products to the market. The move, they say, is aimed at bringing more advanced new technologies to the public.

Believe it or not, medical device manufacturers have been able to expedite their approval processes by simply providing proof that their new products were sustainably equivalent to the ones which had been grandfathered in when Congress first established the pathway, which is known as 510(k).  This process was established all the way back in 1976, and it means that new products aimed at entering the market are getting compared to technology that is several decades old (in many cases).

It is not like new drugs, for example, which must be tested (often diligently) inpatient studies.  Medical devices simply just have to resemble the ones they replace. Indeed, only a few brand new devices have to undergo more extensive clinical testing in order to verify their safety and efficacy.

And the previous FDA framework has been long criticized in government watchdog reports as well as by independent medical experts.

Because of that, the FDA now wants to retire the old products—some of which are not even on the market anymore—and develop an easier way for companies to release new products, explains US FDA Commissioner Scott Gottlieb and Center for Devices and Radiological Health Director Jeff Shuren.

This move from the FDA comes only a day after a published review of a global investigation into the safety of medical devices by more than four dozen media organizations.  The group, led by the International Consortium of Investigative Journalists, found more than 1.7 million injuries and approximately 83,000 deaths that could be associated with outdated medical devices.

Of course, some of the reforms proposed by the FDA could still take a number of years before they can be effectively implemented. In addition, any new guidelines and manufacturing regulation, and the more complex changes could all require an act of Congress.

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