ML-Powered Medical Devices: 10 Tips For Regulatory Compliance

October 11, 2023

Steven F. LeBoeuf, Ph.D.

After having survived several pre-sub correspondence letters from the FDA in pursuit of 510(k) clearance for Valencell’s cuffless, calibration-free fingertip blood pressure monitor (BPM) (Not FDA cleared. Not for sale in the U.S. as of this article’s date of publication), I’ve become familiar with the FDA’s Good Machine Learning Practice (GMLP) for Medical Device Development: Guiding Principles,1 which I like for at least two reasons: 1) it’s a strikingly quick read and 2) it’s spot-on. The guidance document outlines 10 guiding principles, each of which is critical in developing medical devices powered by machine learning (ML). In this article, I summarize the 10 principles and provide real-life examples of how you can employ them.

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