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Which Medical Devices Require Registration in the United States?
Category：行業(yè)資訊 Date：2024-07-24 16:52:53 Author: Source:
In summary, the FDA's medical device registration encompasses a broad spectrum of products crucial to healthcare delivery, ranging from basic tools to complex technologies aimed at diagnosing, treating, and monitoring diseases. Compliance with FDA regulations ensures that these devices meet rigorous standards of safety, effectiveness, and quality, safeguarding public health and facilitating innovation in the medical device industry.

Medical device registration in the United States applies to a wide range of products intended for use in healthcare. The U.S. Food and Drug Administration (FDA) regulates medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Public Health Service Act (PHS Act). Devices subject to FDA registration include those designed for diagnosis, treatment, monitoring, or prevention of disease or other conditions, as well as devices that affect the structure or function of the body.

FDA classification categorizes devices into three main classes based on risk to patients: Class I, II, and III. Class I devices are deemed low-risk, including simple tools like tongue depressors and elastic bandages. Class II devices, such as powered wheelchairs and some pregnancy test kits, are moderate-risk and typically require specific performance standards and post-market surveillance. Class III devices, such as implantable pacemakers and HIV diagnostic tests, pose the highest risk and necessitate FDA's stringent pre-market approval process to ensure safety and efficacy.

Additionally, registration requirements encompass in vitro diagnostic (IVD) devices used in laboratories, which are essential for detecting diseases and monitoring health conditions. These devices include reagents, instruments, and systems intended for the analysis of specimens derived from the human body, providing critical information for medical decisions.1(1).jpg

Furthermore, combination products, which combine drugs, biologics, or devices, fall under FDA jurisdiction. These products, like drug-eluting stents and inhalers with medications, require compliance with regulations from both the FDA's Center for Drug Evaluation and Research (CDER) and its Center for Devices and Radiological Health (CDRH).

In summary, the FDA's medical device registration encompasses a broad spectrum of products crucial to healthcare delivery, ranging from basic tools to complex technologies aimed at diagnosing, treating, and monitoring diseases. Compliance with FDA regulations ensures that these devices meet rigorous standards of safety, effectiveness, and quality, safeguarding public health and facilitating innovation in the medical device industry.

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