Don't take everything FDAers say on faith!

Nor would they want you to. Treat FDAers as humans, understand the context of your conversation, and remember your common goals.

Recently, I have heard a few people talk about what an FDA reviewer said as if it were the gospel. I find myself in the position of suggesting an alternative understanding, and I have to be extremely delicate so that my reputation doesn't become that of an FDA-skeptic (which couldn't be further from the truth).

Every statement made must be taken in context.

"In Got we trust. All others bring evidence." ~Dr. Robert Califf, two-time FDA Commissioner

For example, in the context of a preliminary discussion about a Medical Device Development Tool (MDDT) Qualification, an FDAer said, "I'd recommend submitting multiple MDDTs in this case, instead of just one." Her point was that individual MDDT submissions for smaller use cases would get reviewed faster than one large MDDT submission. I had a different recommendation. In this case, multiple submissions would be (1) less useful for the industry that would adopt the MDDT, and (2) more burdensome to FDA reviewers. I wholeheartedly agreed with her point (that multiple would be easier to get approved), but not her recommendation (that this was the best course of action).

When someone working for the FDA is having a conversation, they're having a conversation. Unless it's in the context of a formal regulatory meeting or written in a former regulatory response document, an FDA employee's comment can be taken with a grain of salt. (Okay, maybe a few extra grains of salt...)

In the context of my work, this happens more often than you would think. I'm focused on raising awareness and adoption of the MDDT Qualification program. It's a relatively new program, voluntary, and not tied to a marketing decision. Companies who have a potential MDDT can approach it with very different strategy than medical device sponsors might approach a 510(k). Not many FDA employees know as much about the MDDT program as my collaborator, Jessica Mavadia-Shukla. Until recently, Dr. Mavadia-Shukla was the FDA MDDT Program Director! Therefore, we must delicately recommend how companies should proceed, anticipating what may happen on the reviewer's side once a submission is made.

I hope this post comes across the way I intend: with empathy and deep respect for FDA employees, encouragement for would-be MDDT sponsors to pursue a sensible strategy, and a reminder to not take any statement at face value if it seems to get in the way of great innovations getting to the people who need them.

~Shannon, the Optimistic Optimizer