Quality Management of Medical Devices - FDA

America, a large consumer of medical devices, enjoys far more advanced medical device manufacturing technology than the other countries in the world. As the first country to manage medical devices, it has established a relatively perfect legal system for the medical device management, which has an important influence on the international community. The US Food and Drug Administration (FDA) is a government agency responsible for the management of medical devices.

FDA has made many associated laws and regulations, including the Food, Drug and Cosmetic Act (FDCA), Quality System Regulation 820 (QSR820), Public Health Services Act (PHSA), Health and Safety Radiation Control Act (HSRCA), and Safe Medical Devices Act (SMDA), etc. Thus, it’s necessary for any medical devices ready to enter the US market to be clearly classified and fulfill the management requirements.

FDA classifies medical devices into three categories(I, II, and III) according to the risk level and management level before they go public. FDA’s supervision of medical devices after marketing is mainly achieved through the Good Manufacturing Practice (GMP), medical device reporting system, medical device tracking system and medical device recall system. FDA clearly specifies the product classification of and management requirements for each type of medical device. Currently, there are over 1,700 types of medical device products in the FDA catalog. FDA implements general control of product I, most of which need to be registered for column names. After meeting the requirements of GMP the products can enter the American market for sale. Product II is under special control; besides registering for the column name, the enterprises need to comply with GMP and submit an application for 510 K. Only when the application is approved, the product can go for sale. Product III (such as cardiac pacemakers, artificial crystals, artificial blood vessels, etc.) requires pre-marketing authorizations. Similarly, the enterprises not only need to register for the column name, but also follow GMP and submit a premarket application (PMA) to FDA. Only with FDA’s approval, the products can enter the market.

The characteristics of FDA’s medical device management can be summarized as follows: first, based on the database of product classification and review principles, a comprehensive definition of medical devices is proposed, and afterward, a judgment basis is put forward for the definition of medical devices and the distinction between drugs and medical devices. Second, the concept of medical device management is presented based on the risk in the medical device classification system and the market access. Third, the implementation of regulations is supervised by medical device manufacturers. In this process, feedback from both the medical device producers and users is also required. Of course, the management of medical devices is centralized and supported by experts.

References

• Part 820 - Quality System Regulation - CFR - Code of Federal Regulations Title 21

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