Regulatory Open Forum

Hi All, 

I'm reading the guidance on supplements for PMA's. It seems FDA supplies the content of Site Change Supplements and 30-Day Notifications. I don't see where they give a content outline for the bare minimum information needed for a 180-Day Supplement. Am I missing it? Or is it just an over of the changes and the required documentation for the change? Thanks 

Hi Anon,

The challenge is that a 180 day supplement can be nearly anything, so it is hard to say a "minimum" set of data needed. Some changes may require new biocompatibility. Some will not. Some might require bench testing - others perhaps not. Labeling may not be required if nothing is changing in it.

I tend to think about 180 day supplements as "updates to all the sections/data/referenced standards in the original PMA that are impacted by the change." That said, obviously a Description of Change section is fairly important. 

Ginger

If it's a change that's primarily manufacturing, I would use the contents from a 30-day and expand on them. If design, I'd think about the contents of a PMA and delete irrelevant sections. Or even look at the 510k contents guidance as a parallel, knowing that many reviewers are familiar with that organization structure. In the past I would have advised looking at RTA checklists. Now that estar exists, you should walk through the estar template and see what sections populate as you answer the questions. That will be closest to your minimum.