FDA announces planned modernization of 510(k) pathway and seeks a more active role in driving technological innovation

On 26 November 2018 Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren issued a joint statement proposing to rebrand and modernize the 510(k) premarket review pathway with the goal of "efficiently advancing beneficial technology to patients, while solidifying FDA's gold standard for safety."

FDA states that its proposal arises out of advances and changes in modern technology in many devices, where new devices generally have increased complexity compared to predicate devices, which may impact safety and performance. FDA issues thousands of 510(k) clearances each year, and changes to this pathway have the potential to have significant impact on the medical device industry. Issuance of the joint statement and proposed modernization plan coincides with mounting negative press calling into question the safety of medical devices that go through the 510(k) pathway. The joint statement paints a high-level picture of how FDA envisions modernizing the current framework, described more fully below. However, the statement provides very few details around the specific changes FDA would seek to implement – changes that may well require congressional action. For example, FDA's statement makes clear that the agency believes new medical devices that come to market under the 510(k) pathway should essentially be better than existing predicates, which is inconsistent with the legal/regulatory standard, which only requires a demonstration of "substantial equivalence."

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