PCCP beyond AI

Very exciting trend of femtech apps integrating with wearable data! How does this work for the regulated ones? I wanted to share this clever use of PCCP from Natural Cycles° from last year which impressed me.

What's PCCP?
Pre-determined Change Control Plan is a regulatory instrument devised by FDA - as a European is I'm most jealous of. It was designed to enable AI devices, which by design need to be able to evolve their accuracy in the field, getting smarter the more data they acquire. Traditionally, any change to the accuracy and performance of a device required a regulatory resubmission (still the case in EU) and up to 90 days of review wait.
With PCCP you can get pre-approval for a reasonable range of performance that you anticipate and accept.

What I found clever, is that Natural Cycles°, the pioneer of regulated fertility awareness, used PCCP not for AI changes but for variability of source data from different wearables.

While, as far as I'm aware, they currently integrate only with ŌURA and Apple Watch, this clears the way for them to swiftly add any more integrations to their conception/contraception suite as long as they fit their predefined specs (see table in pdf).

This is an example of how:
1️⃣ Regulatory instruments that are smart and abreast with the times enable even more innovation than what they primarily intended to,
2️⃣ Femtech is riding the wave of biomarkers ensuring most users can be served irrespective of which devices they choose - it's not just the iOS vs Android divide anymore!
3️⃣ Scientific research and clinical partnerships will see an incredible boost of opportunity from all this data, finally compensating for the lack of data that we know womens health has suffered until now!

What else could we use PCCP for? And until when can we have a similar toolkit in Europe under MDR? 🫠

NC's current integrations here

Link to full 510k summary here