What is the significance of the term "Grandfathered" in relation to regulatory compliance?

The term "Grandfathered" in the context of regulatory compliance is significant because it refers to certain drugs or medical devices that were allowed to remain on the market without undergoing the new approval processes that apply to newer products. Essentially, if a product was legally marketed before certain regulatory changes or standards were established, it can continue to be marketed based on the original approval. This allows established products to remain available to consumers without being subjected to the current regulatory standards, which might require extensive testing or additional documentation for new entrants into the market.

This designation helps facilitate the availability of established medicines or devices that were already considered safe and effective prior to more stringent regulatory requirements being implemented. It provides a balance between protecting public health and allowing for continuity of care with existing therapies or devices.