Qsr820 is the English abbreviation of American medical device quality management system regulations. It is the quality management system regulations that American (human) medical device manufacturers and foreign (human) medical device manufacturers planning to sell their products to the United States must comply with. It is the basic requirement that most medical devices must comply with before they are listed in the United States and may be spot checked at any time after they are listed.

510k, in essence, is a "premarket notification" (PMN) that must be done before medical products are marketed in the United States. It is a section of the act of the food, drug and cosmetics (fd&c) action committee of the United States, and the section of this act happens to be in section 510 of the fd&c act of the United States

The products exported to the United States must be registered with the Federal Food and Drug Administration of the United States, and the action of ensuring that the products comply with the relevant American standards and health and safety requirements. Some of the products must also issue relevant tests before they can be successfully registered.