Recalls 101: New FDA Guidance Gives Basic Advice On Prepping For, Executing A Recall
The US FDA’s final guidance is a basic how-to guide for manufacturers to prepare for and roll out a product recall action.
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty documents have been posted on the tracker since its last update.
Good news for industry: The number of product recalls initiated by device makers and the number of recalled device units both dropped in the fourth quarter of 2021. Check out our Q4 recalls infographic.
In this FINAL EPISODE of Speaking Of Medtech: The US FDA got something it desperately wanted in its latest user-fee package with industry: a Total Product Lifecycle Advisory Program pilot, or TAP. The agency says TAP will allow for earlier and more frequent engagement with developers – but is it needed?