FDA Updates Device 510(k) Approval Regimen to Address Cybersecurity

FDA Aiming to Modernize Pre-Market Notification 510(k) Program Clearance Pathway

FDA Aiming to Modernize Pre-Market Notification 510(k) Program Clearance Pathway

With an eye on keeping up with advances in medical device technology and addressing cybersecurity concerns, the U.S. Food and Drug Administration (FDA) has rolled out its latest regulatory update outlining what it hopes will become a timelier approach to device review and approval.

FDA’s work is an attempt to modernize its Pre-market Notification (510(k)) Program clearance pathway, which accounts for most devices that the agency reviews through the Center for Devices and Radiological Health. “We believe that where appropriate, new medical devices that come to market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria,” FDA said in a release accompanying a new document about the update.

“This is a contemporary approach to regulation,” FDA says. A one-size-fits-all regulatory approach wouldn’t optimize public health outcomes and wouldn’t be efficient in advancing beneficial new technologies to patients, according to the agency.


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At the same time, FDA reaffirms its commitment to the “merits” of the 510(k) process, “but we also believe that framework needs to be modernized to reflect advances in technology, safety, and the capabilities of a new generation of medical devices.”

The 510(k) program was first adopted in 1976, so it’s long overdue for an overhaul, the agency said.

This new action builds on FDA’s April 2018 publication of its  Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health. “We recognized that there were opportunities for us to continue to enhance our programs to help improve device safety,” FDA said. Policy ideas in that document spanned the life cycle for devices, including ways to drive innovation of safer devices in pre-market conditions, and to enhance post-market patient safety.

Author: Michael Causey