Medtech Matters

In the second part of this two-part Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss change management with regard to how to address it with the FDA. The type of change and the overall implications of it to the functionality and efficacy of the device should dictate which route a company should take—letter-to-file or a Special 510k. Specifically, we address a number of questions, including:What is change management and why is it important?How does a company or regulatory individual decide when to handle the change internally, such as via a letter-to-file, vs. notifying the FDA with a special 510k or PMA supplement?Does it matter what type of change is being made? And I have a list of examples. Perhaps we can take these one at a time?Aesthetic change, such as color or size of a font?Design change, such as the shape or size of the device?Material change, such as the replacement of one material with another or the combination of two materials?Labeling