2018 a Record Year for Approval of Novel Medical Devices

By MedTech Intelligence Staff
January 29, 2019


• Categories: 04-Product Design & Development, 05-Quality/Regulatory, Combination Products, Market Access

One of the ways in which FDA measures success in moving medical device innovation forward is through the number of devices that it clears or approves. Following a 40-year record set in 2017 with 99 novel device approvals, last year the agency set yet another record, approving 106 novel devices. In addition, FDA approved or granted nine breakthrough devices.

For the calendar year 2019, “novel devices” are original PMAs, panel track supplement PMAs, de novos, humanitarian device exemptions and breakthrough 510(k)s. Previous to this year, novel devices were original PMAs, panel track supplement PMAs and de novos.

“Our effort to promote innovation is eclipsed only by our commitment to make sure that these products are safe for patients,” said FDA Commissioner Scott Gottlieb, M.D. and CDRH Director Jeff Shuren in an FDA statement. “Our success in providing patients with new treatments and diagnostics, and more options for effective health care, are not coming at the expense of the robust non-clinical and clinical science on which we rely to make our regulatory decisions.”

In the agency statement, Gottlieb and Shuren also alluded to initiatives announced last year, including NEST and the Medical Device Safety Action Plan, which will help to continue to foster innovation. They also said that advances in technologies such as material science, digital health and 3-D printing will continue to push more inventions in medtech.