FDA announces historic 2018 for medical device approvals

The FDA announced that it approved 106 novel medical devices in 2018, surpassing the previous record of 98 set just one year prior. Nine devices also received the agency’s Breakthrough Device Designation.

To show the amount of growth this represents, the FDA noted that just 25 such devices were approved in 2009.

“Our effort to promote innovation is eclipsed only by our commitment to make sure that these products are safe for patients,” Scott Gottlieb, MD, FDA commissioner, and Jeff Shuren, MD, director of the Center for Devices and Radiological Health, said in a prepared 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." 

The statement also explored the FDA’s role in today’s rapidly evolving healthcare landscape.

“It’s vital that the FDA’s regulatory approach continue to evolve and modernize to safely and efficiently advance these opportunities,” Gottlieb and Shuren wrote. “Not only must we keep pace with this complexity and innovation, but we must also stay ahead of the new and evolving risks that can sometimes accompany novel products. We must skate to where the puck will be, and, even better for patients, drive the puck to where it should be. That requires the willingness to embrace and lead change.”