This article examines another major regulatory regime relevant to mHealth application developers – the Federal Food, Drug and Cosmetic Act (FDCA), as well as regulatory issues unique to.
This article examines another major regulatory regime relevant to mHealth application developers – the Federal Food, Drug and Cosmetic Act FDCA, as well as regulatory issues unique to non-US companies.
Trends In FDA Quality System Inspections: 3 Takeaways To Ensure Future Success
By Adam Atherton, KEB, LLC
The FDA conducts thousands of quality system inspections each year. The FDA performs inspections of medical device quality systems for products planned for or already on the U.S. commercial marketplace and publishes summaries of the inspection observations here. In this article, I present background and high-level observations on the inspection data over time. My next article will analyze FY2020 data and how it compares to previous years.
FDA inspections of medical device quality systems are driven by either the older, but still relevant, quality system inspection technique (QSIT) or the more recently developed medical device single audit program (MDSAP) model. It is unknown if these different audit approaches result in different outcomes, but it is unlikely. I expect the MDSAP methodology identifies quality system gaps quicker due to the more rigorous and systematic approach,