The recent FDA device downclassification decision is not good news - for industry or for patients. Several devices on this list - namely ventilators - have benefitted from close FDA scrutiny during the 510(k) submission process. They are safe precisely because they have been so closely regulated, not because they are simple to use and present limited risk to the patient.

This podcast combines three different interviews into one narrative about the FDA decision, the reasoning behind it, and the action we need to take to keep ventilators and other devices under the careful watch of federal regulations.

Link to the original post and instructions for submitting your comments to the Federal Register: https://leanraqa.com/regulatory-quality/fda-down-classified-classification/