As the end of the Emergency Use Authorizations looms somewhere over the horizon, companies are turning their attention to establishing their products as traditionally cleared 510(k) devices. This has resulted in an influx of questions – and a recurring theme. Companies default assumption is that there’s a checklist for FDA clearance. In reality, there’s a process for FDA clearance. Learn how one can set you up for failure and the other for success.
Is Development a process or a checklist? And who cares?
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