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 needed.  Accordingly, such a preventive measure needs to be properly put through a recall trigger assessment process to see if your risk reduction actions meet the risk reduction triggers of applicable recall statutes/regulations/ordinances, etc.  If you aren’t adept at such recall deliberations, then you should consider getting expert assistance.