The FDA issued draft guidance proposing an expanded abbreviated 510(k) clearance program that would allow companies to show a new product’s substantial equivalence to an existing device using performance criteria rather than directly comparing the device’s performance to a predicate device.
The FDA reasoned that substantial equivalence based on a legally marketed device that has the same intended use and suitable technological similarities can mean basing clearances on predicate devices that are many years old.
Under the expanded abbreviated 510(k) program, if a device meets performance criteria relevant characteristics for safety and effectiveness and a new device meets or exceeds the same levels, the agency could deem the device as safe and effective as the predicate instead of requiring a direct comparison.
Individual submissions for the expanded abbreviated 510(k) program will still require the identification of predicate devices for the technological characteristics and intended use portions of evaluating substantial equivalence.
The agency said the finalized guidance “could reduce regulatory burdens while maintaining standards for safety and effectiveness and providing patients and healthcare professionals with greater confidence that the device meets modern performance standards.”
The FDA plans to offer information about device types to which the performance criteria would apply, including appropriate intended uses and indications for use, technological characteristic expectations and the relevant product code.
Read the guidance here: www.fdanews.com/04-12-18-510k.pdf. — James Miessler