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FDA approves record number of medical devices

Michael Kochman, MD, AGAF, comments on FDA’s steps to streamline the device approval process.

In 2018, FDA approved 106 novel medical devices, up from 99 in 2017. In a recent statement, FDA discussed its efforts to bring innovative devices to market while keeping patient safety as the top priority. We asked Dr. Michael Kochman, past chair of the AGA Center for GI Innovation and Technology (CGIT) and member of the FDA GI-Urology Devices Panel, to comment on the current device approval climate.

“Innovation is alive and well; FDA continues to evaluate and approve novel devices at an increased rate and approval efficiency has improved. The implementation of the National Evaluation System for Health Technology (NEST) is an important milestone to ensure the ongoing safety of medical devices that will be placed into use. The Safer Technologies Program (STeP) is another potentially patient focused program to provide ongoing surveillance and assurance of safety of devices already in use.

“Over the past few years FDA and the AGA CGIT have collaborated on a number of critical endeavors which are aimed at improving patient access to safe and effective medical devices. AGA and FDA worked together on obesity devices and have refined the acceptable risk benefit paradigm. Other critical collaborations both through AGA CGIT key opinion leader meetings and as part of the FDA expert network have fostered important premarket and postmarket collaborations.”

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