In the first part of this series on medical device regulation in the USA, we are discussing the chronology of the regulation.
Material composition: The Food and Drug Administration (FDA) is the regulatory agency in the United States of America responsible for protecting and promoting the development of human and veterinary drugs, biological products, medical devices and radiation-emitting products, human and animal food, and cosmetics.
The First Regulation Act: In 1906, the federal food and drug legislation act was designed to protect A1mericans against threats from harmful substances and deceptive practices. However, during this period no act was defined to regulate medical devices, no one could imagine how medical device technology would grow, change and, like food and drugs, need to be regulated during the coming years
Amendment in Regulatory Act: In 1938, the Federal Food, Drug, and Cosmetic Act (FD &C) authorized the FDA to regulate medical products, which allows the FDA to perform factory inspections and prohibited misbranded marketing of therapeutic medical devices. After that, lots of acts came into force, and until the 1960s devices were subject only to policing by the FDA. The agency determined whether a device was safe and effective without pre-market testing, review, or approval.
Major Adverse Events Reports: In the early 1970s, an intrauterine contraceptive device (IUD) manufactured by A.H. Robins company became the most popular, and around 2.2 million women were prescribed by physicians after three years on the market. In 1971, the first issue of septic infections and other complications were reported using this IUD. Due to this, in 1973, the US Centers for Disease Control and Prevention (CDC) conducted a study on the safety of IUDs and revealed that it can cause hospitalizations, death, and other complications. Moreover, during this period, one more device, pacemaker failure, was reported in the US also.
1976: Medical Device Amendments to thFe FD&C Act
- After these two incidents in 1975, a hearing took place, and finally in 1976 Medical Device Amendments to the FD&C Act came into force with some specific objectives related to safety of the medical device as below:
- Intended to provide reasonable assurance of the safety and effectiveness of medical devices
- Created a three-class, risk-based classification system for all medical devices.
- Established the regulatory pathways for new medical devices (devices that were not on the market before May 28, 1976, or had been significantly modified) to get to market:
1. Premarket Approval (PMA)
2. Premarket notification (510k) - Created the regulatory pathway for new investigational medical devices to be studied in patients (Investigational Device Exemption (IDE))
- Established several key post-market requirements: registration of establishments and listing of devices with the FDA, Good Manufacturing Practices (GMPs), and reporting of adverse events involving medical devices
- Authorized the FDA to ban devices
In the coming parts of this series, we will look at each of the regulatory pathways more closely Meanwhile, check out our services to gain access to the US market.
