Pre-Submission to Preeminence: Showcasing FDA's Latest Pre-Sub Guidance and Uncovering PCCP Best Practices

Recorded 29 June 2023



3:17 -- What are the major changes to the new FDA guidance?
6:21 -- Let's get into the do's and don'ts of pre-submissions... what are some best practices?
12:04 -- Are informational meetings done through the Q-sub process? How do you set up an informational meeting with the FDA?
13:43 -- What is a PCCP and how can it be beneficial?
24:28 -- What are some of the most common misconceptions when it comes to PCCPs?
26:23 -- How do you discuss everything in the one hour meeting with the FDA that's in the content within appendix A?
29:16 -- What have your conversations been like so far with the FDA about PCCPs?
32:23 -- Is there a specific format or template for PCCPs?
35:23 -- Could you elaborate on what is in scope and out of scope? If changes to architecture, training, and thresholds are out of scope, what's actually in scope?
40:44 -- What are the bounds of a PCCP? If in version two of your device you are planning to expand indications for use which would normally require a new 510(k), could a PCCP allow for this type of change to be done without an additional 510(k)?
43:38 -- Do you see parallels between the types of changes submitted in a special 510(k) and those included in a PCCP?
 48:35 -- When preparing a PCCP, what do you suggest would be the first step to take?
52:58 -- Does the PCCP apply to any algorithm-based SaMD? Not all algorithms are based on machine learning but still will be improved over time.
53:40 -- Does the FDA expect an estimated time frame for when a manufacturer expects to make a PCCP modification?
56:43 -- Is there a good way to search for devices that have associated approved or cleared PCCPs?
57:59 -- Is there anything you as a panel, who have worked at the FDA or interact with them frequently, that would comment or disagree with in the draft guidance in regards to being "least burdensome" approach?
1:00:22 -- Any takeaway messages or last pieces of advice? 

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