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The Birth of Medical Devices in the United States: What is the Story Behind the FD&C Act of 1938?
The history of medical devices can be traced back to ancient times. However, it was not until 1938 that the United States began to formally regulate medical devices. This year, the passage of the Federal Food, Drug, and Cosmetic Act (FD&C Act) marked the arrival of an era in which the safety and effectiveness of medical devices have received unprecedented attention.
Medical device refers to any device used for medical purposes. These devices are accompanied by certain potential dangers during use, so they must be tested to prove safe and effective.
Under modern standards, the definition of medical device includes not only simple tools, such as tongue depressors or medical thermometers, but also many complex and high-risk devices, such as pacemakers and various implants. The safety and effectiveness of this type of equipment became a legislative priority after the passage of the FD&C Act.
The passage of the FD&C Act was due to many medical accidents in the early 20th century. At the time, some untested drugs and devices were causing massive patient harm, creating greater public demand for regulation of medical products. Due to the lack of effective management, many unlicensed medical products are circulating in the market, threatening patient safety.
The core of this bill is to require that all medical devices must be verified for safety and effectiveness before being sold, so that they can obtain government approval.
After the "FD&C Act" became law in 1938, the U.S. Food and Drug Administration (FDA) began to shoulder the task of supervising medical devices. This not only increases the regulatory power over medical devices, but also significantly improves the safety standards of medical products. In the following decades, the regulations and standards for medical devices were further strengthened, especially in 1976, with the passage of the Medical Device Amendments, which further established a specialized medical device regulatory system.
Unlike the United States, Europe’s medical device supervision takes a different approach. The Medical Device Directive (MDD) was not introduced in Europe until 1993, and was subsequently replaced by the Medical Device Regulation (MDR) in 2017. The introduction of this series of regulations marks the gradual beginning of the standardization process of global medical device supervision.
The global medical device market was estimated to be between US$220 billion and US$250 billion in 2013, with the United States accounting for approximately 40% of the market share.
There are also some differences in the definitions of medical devices in various countries, especially the differences in risk classification. The US FDA divides medical devices into three categories; while the EU divides them into four categories. These classifications not only affect market access, but also affect the research and development of medical devices and the business strategies of enterprises.
For example, in the United States, Class III devices such as pacemakers must undergo strict premarket approval, which means developers need to provide sufficient clinical data to prove that the product is safe and effective. sex. In the EU, the classification of medical devices also defines different regulatory requirements based on risk.
The successful research and development of medical devices often relies on interdisciplinary cooperation, especially the development of the field of biomedical engineering, which further promotes innovation and improves product safety.
With the advancement of technology, future medical devices will be more efficient and more intelligent. However, this also brings new regulatory challenges. In particular, many modern devices have embedded software, which makes regulating them even more complex. As emphasized by the FDA and relevant European agencies, data security and product reliability have become new focuses.
So, in the face of evolving medical technology and regulatory needs, how will future medical device supervision adapt to these changes and ensure patient safety?
