Today Rob Packard recorded an updated version of the 2015 webinar about predicate selection. This is one of webinars that comprise Medical Device Academy's 510(k) Course that is available as a bundle for sale.

The recording was 1 hour and 1 minute in duration. There were 22 slides presented, but Rob also demonstrated how to use the following FDA databases:
- Registration & Listing
- Product Classification
- TPLC

In addition, a new software tool was demonstrated as another method of searching for potential predicate devices. The tool is licensed from Basil Systems, and the ability of the software to automatically create a "predicate tree" and provide quick access to all of the potential 510(k) summaries within a product classification is impressive.

We covered strategic considerations when selecting a predicate device for your 510(k) submission. We demonstrated how to enter your predicate selection into the new FDA eSTAR templates, and we identified all of the locations in a 510(k) submission where your chosen predicate is referenced.

If you are unable to identify a suitable predicate selection for your 510(k) submission, then you have five options. These five options were also the subject of a blog posting written in 2015:
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At the conclusion of the webinar Rob announced the next webinar planned for updating to the FDA eSTAR templates, and he shows you where you can cast your vote for the next webinar to update (click on the link for our poll):
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If you would like to schedule a call with Rob, please use the following calendly link:
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