FDA’s New Device Reclassification Process - Webinar CD/Transcript
FDA’s New Device Reclassification Process: How New Criteria May Impact Your Device
Just a few weeks ago, the FDA issued proposed regulations that allow it to reclassify a device by administrative order rather than by regulation.
It's a significant change that the agency hopes will bring clarity to the classification and reclassification process.
Order this webinar CD and transcript to find out.
By modifying the Class III device definition, the FDA is trying to be clearer about which devices now classified as Class III cannot be "down-classified." And which ones can.
But there's more. "New information" could result in a device being "up-classified." But some "automatically classified" devices might be down-classified.
Oh yes, "pre-amendment" devices WILL be affected by the new proposed regulations.
To help you get a handle on the changes, FDAnews has engaged three experts from Morgan Lewis FDA Practice.
In an intensive 90-minute session, they take you by the hand and walk you step-by-step through the complexities of the proposed regulations.
To do this, they present two distinct, detailed flow charts that make comparing the old and the new classification and reclassification processes significantly easier:
Flowchart #1 reviews the current reclassification process, in use prior to the issuance of the proposed regulatory changes.
Flowchart #2 outlines the new proposed reclassification process, as initiated by the FDA (or by a petitioner).
Clearly, this in-depth webinar CD and transcript is a must for device manufacturers.