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Hitec Medical FDA training -FDA’s Definition of Medical Devices

FDA’s Definition of Medical Devices

Medical devices refer to instruments, devices, tools, machinery, instruments, insertion tubes, in vitro reagents, or other related items that meet the following conditions, including components, parts, or accessories: those explicitly listed in the official National Formulary national prescription collection or the United States Pharmacopeia or attachments to the aforementioned two; Intended for use in the diagnosis of animal or human diseases or other physical conditions; Or used for the cure, alleviation, or treatment of diseases; Intended to affect the function or structure of an animal or human body, but without relying on chemical reactions in the animal or human body or body to achieve its primary purpose, and without relying on metabolism to achieve its primary purpose.

FDA’s classification of medical devices

Class I General Control

Class II general control+special control

Premarket Notification (PMN), 510 (K)

Class III General Control+Pre Market Approval

Premarket Approval (PMA)

The principle is to classify products based on their level of risk.

The FDA currently has over 1700 categories of devices, divided into 16 specialized application areas.