FDA’s New Guidance on PMA Supplements: Are You Properly Reporting Changes in Your Products
Product Details
For years, devicemakers have asked the FDA to clarify how and when to report changes in PMA-approved devices. Unfortunately, the final guidance issued December 11, 2008 still leaves you guessing how to avoid 483s and warning letters.
The new guidance identifies the PMA supplements you can choose from and situations where a 30-day notice is appropriate. But there’s no decisionmaking chart or definitions of critical terms like “substantial clinical data.”
Bottom line: the FDA stops short. Is there anywhere else to turn?
You bet there is …
Expert help on PMA supplement questions the FDA doesn’t answer
Don’t wait any longer to get the practical know-how the FDA’s final guidance on PMA supplements fails to provide. In this 90-minute audio CD/Transcript, regulatory and medical device authority John Smith helps clear the confusion on how to change everything from laboratory quality control to plant engineering — so you’ll have the information you need to comply with reporting of changes in PMA-approved devices.
You’ll come away ready to create a decisionmaking process you can use to modify design, labeling and manufacturing without getting devices declared misbranded!
Order now for your entire team to learn when and how to use PMA supplements, including:
- Key differences between the final guidance and what devicemakers expected to see
- Which product modifications require a PMA supplement
- Panel track, 180-day, real-time, changes being effected, manufacturing site change: What you should know about each type of PMA supplement
- How to determine which supplements to use for your specific situation
- When changes to design, labeling or process require an all-new PMA
- How to translate the FDA’s hypothetical examples into solid definitions of regulatory terms and a clear decisionmaking process
- How the new PMA-supplements guidance changes what the FDA expects to see in your annual report