Hi All,

This situation is usually handled on a case by case basis. In some cases, when the regulation is changed or updated, guidance documents are issued to explain the timeframe of implementation and the criteria that must be met for devices to be grandfathered into the old regulation. From my experience, if the regulation changes before design freeze, the manufacturer MUST implement the new regulation and no grandfathering is allowed. The situation is different if the regulation changes after design freeze. In some cases where the regulation changes before the device is filed for approval with the regulatory agencies, A gap analysis is required with a rationale of whether the new regulation will be implemented or not. If the regulation changes after the approval is obtained, based on the regulation, the manufacturer may be eligible for grandfathering.

-Fady Khalla