Legacy Product

Legacy Product refers to an older product that is still on the market but may no longer conform to current standards or regulatory requirements. In FDA-regulated industries, a legacy product can include pharmaceuticals, medical devices, or other regulated items that were originally developed and approved under older guidelines but continue to be sold without undergoing complete modernization or redesign.

For medical devices, legacy products may fall under FDA guidelines that are less stringent than current 21 CFR 820 regulations. Over time, companies may need to evaluate and update these products to meet evolving standards, including ensuring compliance with current design control, risk management, and quality systems.

Managing legacy products often involves balancing compliance with the cost and feasibility of redesign or retesting. Firms must ensure that legacy products remain safe, effective, and compliant with current regulatory expectations.

Legacy products in pharma are frequently generics and commodity products with low profit margins kept on the market as a service to consumers. For more on this, read our post on GMP Compliance for Legacy Products.