The Medical Devices Introductory Course 2020

A Brief History of Regulation Drugs, Devices and Combination Products

The regulation of drugs as we know it today developed after the Thalidomide disaster

•1960 Pharmaceutical Affairs Law (revision of previous laws) •1962 Kefauver-Harris “Drug Efficacy” Amendments •1962 Food & Drugs Act Amendment •1963 Rules on Drug Administration •1965 EEC Medicinal Products Directive (MPD) (65/65/EEC)

The regulation of devices as we know it today began after the Dalkon Shield and pacemaker safety issues of the early 1970’s and much later in many other markets •1976 Medical Device Amendments •1993 EU Medical Devices Directive (MDD) (93/42/EEC) •1995 Medical Device Regulations (implemented by State Drug Administration) •1998 Medical Device Regulations (revising the previous notification system under the Bureau of Medical Devices

Specific regulations for combination products began only recently •(1986) / (1997) / (2004) / 2013 Kit Products / Combination Product Notifications

•1990 Safe Medical Devices Act (21CFR3) / 2002 MDUFMA Establishment of Office of Combination Products / 2005 Final Rule on Definition of Primary Mode of Action (21CFR 3.4) / 2013 Final Rule on cGMP for Combination Products (21CFR4)

Clinical Investigations

The Organisation for Professionals in Regulatory Affairs