FDA registration of medical devices: When do I need to submit 5 10 k?

Most second-class medical device products are exported to the United States, and they need to obtain 5 10(k) before they can be registered with the FDA.

I. The meaning of 5 10(k):

Document 5 10(k) is a pre-marketing application document submitted to FDA. The purpose is to prove that the device applied for marketing is as safe and effective as the legally listed device that is not affected by the pre-marketing approval (PMA), that is, the equivalent device se (essentially? Equivalent). The applicant must compare the device applied for marketing with one or more similar devices on the American market at present, and draw and support the conclusion of equivalent devices.

Second, the reference of 5 10(k) must be submitted:

1. Domestic manufacturers that introduce medical devices into the US market;

2. Regulators who introduce medical equipment into the American market;

3, change the label or operation seriously affect the repackaging or relabeling of medical devices;

4. Foreign manufacturers/exporters or American agents of foreign manufacturers/exporters who introduce medical devices into the US market.

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