FDA’s multi-layered rules for product recalls – corrections or removals of marketed devices that don’t comply with FDA rules – represent a double-edged sword.
If you’re not careful, it’s easy to under-report recalls. On the other hand, a quick reading of the regulations can cause you to over-report, needlessly shaking patient confidence and shareholder value.
How can you make the right decisions and ensure compliance? Start by understanding the key rules in play, then use a four-step decision process (outlined in Exhibit 1) to more efficiently and thoroughly meet your FDA obligations for product corrections or removals.
Exhibit 1: 21 CFR Part 806 Process Flow (Click to view larger PDF)