February 24, 2023 What if I Add an Expiration Date for Risk Reduction? If, to reduce risk, you are adding an expiration date to a medical device model for which previously-marketed units do not have such an expiration date, then, generally speaking, the governing regulatory authorities will reflexively suspect/assert that a recall might be […]
<h1 class="entry-title">Category: Corrections & Removals</h1>
FDA 21 CFR Part 7 vs. Part 806: What’s the Difference?
January 26, 2023 FDA 21 CFR Part 7 vs. Part 806: What’s the Difference? The most succinct way I’ve seen FDA correlate 21 CFR Part 806 with 21 CFR Part 7 is by stating that Part 806 reports of corrections and removals are required for Part 7 Class I and Class II recalls, yet […]