ARTICLES BY ADAM ATHERTON
Despite a substantial reduction in the number of inspections that the FDA conducted in FY 2021, the 483s that the agency issued are still very important for the medical device industry to take note of. What were the top 3 citations, and how do the rest of the top 10 compare? This author shares all the data, as well as the 4 priority takeaways.
Collaborative communities are a global grassroots effort convened by interested public and private stakeholders who work to solve shared challenges and achieve common goals related to medical devices. These communities do not replace established regulatory mechanisms, are not federal advisory committees, and are not chaired or convened by the FDA, but FDA may participate. Here are the descriptions, goals, and contact information for each of the 12 collaborative communities that have FDA CDRH participation.
The first article in this series discussed the background and a few high-level observations of the FDA’s summaries of its medical device quality system inspections. This article digs into the details of the FY2020 observations. What were the top 10 most-cited issues, and what are the takeaways you can implement?
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. This article presents background and high-level observations on the inspection data over time, revealing 3 key takeaways.