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FDA Breaks Record for Medical Device Approvals in 2018

January 30, 2019


It’s an unprecedented time for innovation and regulation in medical devices. The Food and Drug Administration announced that 2018 was their most successful year in approving medical devices. 106 devices received the FDA’s marketing green light, breaking the record of 99 in 2017.

These devices included automated insulin dosing systems for children as young as 7, the world’s smallest heart valve for newborns, the first mobile medical app to help manage opioid and substance abuse disorders, and artificial intelligence technologies that diagnose diabetic retinopathy.

This follows the FDA’s plans to improve their medical device regulations. In November 2018, they announced plans to “modernize” the 510(k) review process to improve the safety of new devices. These plans included enforcing the use of predicates that were based off of modern technologies and making previous predicates ineligible. They’ll continue improving NEST (National Evaluation System for Health Technology), a plan started in 2016 to improve post-market surveillance and analysis of medical devices. They’ll also update safety and performance criteria of well-known technologies, and improve criteria for devices intending to treat non-life-threatening conditions by employing principles from their Breakthrough Device regulation rules.

In a statement, Dr. Scott Gottlieb and Dr. Jeff Schuren spoke of the FDA combined commitment for innovation and safety:

“Spurring innovation to develop safer, more effective devices is key to improving patient safety. We are equally committed to advancing safe and effective products that can address unmet medical needs to reduce the health effects from disease. Both objectives are essential to meeting our public health mission, resulting in more lives saved and improved quality of life.”

Read Full Article at the Source: FDA Approved a Record High of 106 New Medical Devices in 2018 | Medgadget

Written by: Ben Ouyang

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