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How We Develop AI for 510(k)-Cleared Devices


How We Develop AI for 510(k)-Cleared Devices
by Grace Adams and Yujan Shrestha, MD on January 26, 2021
Want to know how we develop safe, effective, and FDA compliant machine learning algorithms? This article describes how we develop machine learning algorithms, points out common pitfalls, and makes documentation recommendations.
When developing a machine learning or AI algorithm, it’s easy to become overly focused on making the best model possible. While model performance is important, to incorporate the model into a commercial medical device, you’ll need to be able to demonstrate to the FDA that the model is safe and effective. Therefore, it’s critical to thoroughly document the algorithm’s development lineage in your design history file. The process outlined in this article will help you do this. We’ve used it to develop AI algorithms within a recently 510(k)-cleared class-II medical device for one of our clients. ....

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Increased Post-market Surveillance For Medical Devices Coming To Canada - Food, Drugs, Healthcare, Life Sciences


Post-market surveillance for
medical devices: Amendments to the
Medical Devices
Regulations (MDR) are being made to impose additional
post-market reporting requirements for Class II, III and IV medical
devices.
Medical device license holders and
importers will be required to proactively report certain foreign
risk communications and actions to Health Canada.
Medical device license holders will
also be required to create and retain summary reports which address
adverse effects, corrective actions, complaints and incidents.
Health Canada s power to
order assessments, studies and tests: Amendments to the
MDR and
Food and Drug Regulations (FDR) clarify the
conditions under which Health Canada can order license holders to ....

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