FDA approved record number of novel devices in 2018

A record number of novel devices were approved by the  US Food and Drug Administration (FDA) in 2018, the federal agency has said.

On January 28, the FDA  announced that 106 novel devices were approved in 2018.

This surpassed the 99 given the green light in 2017, which at the time was the highest in 40 years.

The FDA said the 2018 figure was the latest in eight years of steady improvement. It added that the annual number of novel, safe and effective technologies it approves “is one measure of its success in advancing device innovation”.

The agency also named examples of innovative products which came to market in 2018, including an automated insulin-dosing system that can be used by diabetes patients as young as seven, and the world’s smallest heart valve for newborns.

Other inventions approved in 2018 were the first blood test in the world to evaluate concussion, the first mobile medical app to help treat substance abuse disorders, and technologies which use artificial intelligence to detect diabetic retinopathy in adults with diabetes.

While the FDA approved a record number of novel devices in 2018, it said the approvals were not at the expense of robust regulatory decisions to make sure that products are safe for patients.

The agency said it will continue to do this in 2019 and move forward with plans to implement the  National Evaluation System for Health Technology. This is a system which will generate “better evidence for medical device evaluation and regulatory decision-making”, the FDA said.

The FDA also hopes to promote innovation by driving competition for developing safer devices.

It said it had recently finalised guidance to produce a “Safety and Performance Based Pathway”, which companies will use to demonstrate that their devices meet the safety and performance criteria developed by the FDA.

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