FDA breaks record for medical device approvals in 2018

In 2018, the FDA approved a total of 106 new medical devices including medical imaging technologies—surpassing their record in 2017 of 99 novel device approvals, according to a recent statement from FDA Commissioner Scott Gottlieb, MD, and Jeff Shuren, MD, director of the Center for Devices and Radiological Health. Last year the FDA approved or cleared nine devices with Breakthrough Device Designation

“Our effort to promote innovation is eclipsed only by our commitment to make sure that these products are safe for patients,” Gottlieb and Shuren wrote. “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.”  

Beginning this year, the FDA will officially recognize original pre-market approvals (PMAs), panel track supplement PMAs, de novos, humanitarian device exemptions (HDEs) and breakthrough 510(k)s as “novel devices."

This year, the agency also plans to move forward and implement the National Evaluation System for Health Technology and continue to establish pre-market pathways that will help novel products reach the market faster and drive competition for developing safer devices, according to Gottlieb and Shuren.  

Such efforts were done last week when the agency released a finalized guidance establishing framework for an alternative 510(k) pathway proposed in April, called the FDA’s “Safety and Performance Based Pathway."

The FDA also plans to issue proposed framework for the Safer Technologies Program (STeP), according to the statement. To do this, Gottlieb and Shuren explained the FDA will consider how to apply Breakthrough Device principles and features to products intended to treat or diagnose non-life-threatening diseases or conditions, but which offer substantial safety innovations that either reduce the occurrence of a serious adverse event or other safety issue, address a known device failure mode or common user error or provide significant safety advantages for users.  

“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.”  

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