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FDA Announces Plans to Improve Approvals Process for Medical Devices

Posted on January 15th, 2019 by in Pharma R&D

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In the pharmaceutical industry, safety protocols are rigorous. Clinical trials, a lengthy and intense part of the drug development process, are deemed absolutely crucial to ensuring the safety and efficacy of new drugs and therapies. There are also many regulations designed to make certain that high standards are maintained during the various trial phases.

However, it’s a very different situation for medical devices, which are cleared by the FDA at a very high rate through processes that many critics view as entirely too lax. “Unlike new pharmaceuticals — which are tested in patient studies — most medical devices only have to show that they are similar to devices already on the market,” writes reporter Matthew Perrone for AP News. “Only a handful of truly new devices must undergo extensive clinical testing to verify they are safe and effective.”

The recently-published findings of a year-long investigation conducted by the International Consortium of Investigative Journalists (ICIJ) point to the need for updated standards in medical device safety. While the report acknowledged that medical devices do, of course, save many lives, it was critical of how little testing is done in humans prior to putting devices on the market. “Manufacturers, doctors, and others potentially linked more than 1.7 million injuries and nearly 83,000 deaths to medical devices in reports to U.S. regulators over the last decade,” stated the ICIJ.

As Angelica LaVito of CNBC explains, “Since 1976, manufacturers have been able to pursue an expedited approval process if they could prove new products were substantially equivalent to those that were grandfathered in when Congress established the pathway, known as 510(k). That means some new products entering the market are comparing themselves to technology that’s decades old.”

Accordingly, the FDA has just announced that it will be overhauling this approval system and modernizing the 510(k) pathway, in order to keep up with rapidly changing technology. “We believe that where appropriate, new medical devices that come to market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria,” announced FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health in a November 26, 2018 statement on the changes.

As the full statement makes clear, improving the approval process for medical devices is a complicated and multi-step process, but a necessary and overdue one. Ensuring the safety and reliability of medical devices (which both save lives and vastly improve their quality) will be better in the long run for patients and manufacturers alike.


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