FDA Issues Stem Cell Treatment Warning, Signals Increased Enforcement

Katherine Sale

On Dec. 20, 2018, the Food and Drug Administration (FDA) issued a warning letter to Genetech Inc., citing numerous deviations from current good manufacturing and tissue practices discovered during a June 2018 facility inspection.

FDA Prepares to Modernize Its 510(k) Pathway to Keep Pace With Medical Device Advancements

Katherine Sale

Most medical devices used in the United States are cleared for marketing through the Food and Drug Administration’s (FDA) 510(k) pathway. Established by the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetics Act, the 510(k) pathway is based on the concept of substantial equivalence. A manufacturer must demonstrate that its product is as safe and effective as a predicate device that has already been cleared and is a legally marketed product.