The Medical Devices Introductory Course 2020

A History of Regulation

http://www.fda.gov/downloads/aboutfda/whatwedo/history/productregulation/promotingsafeandeffectivedrugsfor100years/ucm11446 9.pdf

A Brief History of Regulation Key events that shaped drug and device regulation

Many of the key changes and developments in the regulation of drugs and devices have

been reactive and driven or hastened by scandals or tragedies prompting action (often

previously considered but not acted upon):

•Diphtheria antitoxin  1902 Biologics Control Act

•“The Jungle”, “Great American Fraud” and “Patent Medicines”  1906 Pure Food & Drugs Act

•Elixir Sulfanilamide  1938 Food Drug and Cosmetic Act

•Thalidomide  1962 Kefauver-Harris Amendments

•Dalkon Shield and Pacemaker failures  1976 Medical Device Amendments

•Bjork-Shiley Heart Valve  1990 Safe Medical Devices Act

•PIP breast implant scandal  EU MD Joint (or “PIP”) Action Plan and proposed new MD Regulations