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eac25 replied to the topic FDA Recall…Now What? in the forum Project Management Process and Medical Device Development 8 years ago
I think depending on the severity of the reason for recall, a number of scenarios could occur. For a situation where the risk to the consumer is small to moderate, as is with this EpiPen recall, the previous responses are the way to go: pushing an ECO and following through on the process. However, is risk is high enough and/or if consumers make enough bad press, like with the Samsung Galaxy Note S7 hubbub, I imagine a simple ECO won’t do. If this is the case, a company may end up redoing the entire project from the start since such glaring issues weren’t avoided the first time around. Whether the company decides to keep the same product is ultimately up to them. Supposedly the Galaxy Note 7 is coming back under the same name, so at least Samsung feels like the name hasn’t been completely ruined.