New 510(k) Draft Guidance Focuses On Assessing Differences Between Device Iterations

On July 14, 2014, FDA issued new draft guidance explaining its current thinking on approaching the premarket clearance process for moderate-risk medical devices. The Agency withdrew its prior guidance on the subject after the FDA Safety and Innovation Act of 2012 called for an overhaul of the 510(k) process. The new draft guidance devotes significant content to helping industry and FDA staff evaluate differences between new devices and predicate devices, particularly when new technological characterizations are involved. The 510(k) process allows companies, in their submissions, to rely heavily on a predicate device's safety record and prior clinical evidence by demonstrating substantial equivalence. The new draft guidance elaborates on the...