4. History of Medical Device regulatory framework in the US

History of Medical Device regulatory framework in the US

In the US, the Federal Food Drug and Cosmetics Act (FD&C) from 1938 extended prohibition of interstate commerce to misbranded and adulterated cosmetics and therapeutic Medical Devices. As the next step in 1944, the Public Health Service Act regulated laboratories and the control of biologic products and biologicals. In 1968 the Radiation Control for Health and Safety Act was directed at minimising exposure to radiation and intense magnetic fields and created performance standards for radiation-emitting machines like X-ray, microwaves etc. From 1970 the Cooper Committee advised regulation on Medical Devices leading to the Medical Device Amendments of the FD&C act in 1976. This laid the foundation for the regulations on Medical Devices. It created a three-class, risk-based classification system for all Medical Devices and established the regulatory pathways for new Medical Devices: Pre-Market Approval (PMA) for new and “high risk” devices and the premarket notification (510(k)) for the substantially equivalent devices to previously marketed devices. The Safe Medical Devices Act (SMDA) in 1990 increased the requirements, notably the level of reporting and post-market surveillance. The 1997 Food and Drug Administration Modernization Act (FDAMA) created the option of accredited third parties to conduct initial premarket reviews for certain devices and established the De Novo program through which novel low-to-moderate risk devices could be classified into Class I or II instead of automatically classifying them into Class III. The regulation continued to evolve after a series of Medical Device Amendments Acts, notably through the 2016 “21st Century Cures Act”, which mandated the creation or revision of policies and processes intended to speed patient access to new Medical Devices and the 2017 Food and Drug Administration Reauthorization Act (FDARA), requiring the FDA to conduct at least one pilot project to explore how real-world evidence can improve post-market surveillance.