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Device Recalls
Versus Device Enhancements

How to know when a product recall or other recovery effort is truly necessary

Determining whether a recall is required is not always a straightforward process, and until it issued its draft guidance in 2013, FDA guidelines have been vague on the matter.

Learn the key takeaways from the guidance including definitions of each action along with examples of real-world scenarios.

What you'll find inside:

• Definition of a recall under the guidance
• The definition of an enhancement under the guidance
• The key factors to consider when deciding to recall a product