Six steps to obtaining 510(k) premarket clearance for medical devices

Companies that think about regulatory strategy in the early stages of medical device development can benefit from greater control of the FDA authorisation process. For those following the premarket notification 510(k) route, this may lead to a quicker, more cost-effective journey from concept to clearance. It’s also possible for companies to obtain FDA feedback on their proposed regulatory strategies via the pre-submission process. According to Laurie Clarke at our sister company TSG Consulting, this voluntary step can make a significant positive difference to FDA decisions regarding 510(k) submissions and/or review timeframes. This is especially useful when it is not clear whether FDA would agree with proposed predicate device(s) and/or the type and amount of performance data needed to demonstrate substantial equivalence.

In the below article, Laurie outlines six key steps of an effective regulatory strategy for medical devices.