In February 2019, FDA published a final guidance document that expanded parts of its 510(k) premarket notification program. The guidance establishes a new pathway: The Safety and Performance Based 510(k). With this novel premarket pathway comes several new opportunities and benefits to device manufacturers, plus some challenges. Understanding these benefits and challenges together—as well as where the Safety and Performance 510(k) fits in the premarket environment—can help your organization better navigate your device’s path to regulatory submission.
> > What the Safety and Performance 510(k) Means for Medical Device Manufacturers