Roadmap to Medical Device Recalls

Summary

When an FDA-regulated product is either defective or potentially harmful, the most effective means for protecting the public is to correct the problem or remove the product from the market with an effective recall program. Properly handled, a recall program can minimize the risk of major FDA enforcement activities and minimize further expensive product liability risks. On the other hand, a poorly handled or superficially acknowledged product problem can and have led to major FDA enforcement activities, enormous product liability payouts and even criminal prosecution & penalties. This white paper provides guidance on what to do when a company learns that there is a problem with one of their medical devices.

A recall proposes a correction or a removal, depending on where the action takes place. This “Roadmap” will ease you through the entire process from initiation, notification, strategy to termination.