The U.S. FDA has a clear and strict definition of medical devices, which is as follows: "A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory, which is: recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them; intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals; or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

Only products that meet the above definition are considered medical devices. Under this definition, not only various instruments and tools in hospitals but even consumer products such as eyeglass frames, lenses, toothbrushes, and fitness equipment like massagers that can be purchased in general stores fall under FDA regulation. This differs slightly from the domestic recognition of medical devices.

(2) Categories

The FDA has established a classification system for approximately 1,700 types of medical devices, categorizing them into three classes based on risk and intended use.

Class I: General Controls (Exempt, Non-Exempt)

Class II: General Controls and Special Controls (Exempt, Non-Exempt)

Class III: General Controls and Premarket Approval

Among these, Class I products have the lowest risk, while Class III products have the highest risk.

If a product is classified as Class I or II and falls under an exempt category, it can be legally sold after company registration and product listing.

If a product is classified as Class I or II and is non-exempt, it must comply with 510(k) requirements before being marketed.

If a product is classified as Class III, most require a Premarket Approval (PMA) application, while a few may comply with 510(k).

(3) How to Determine Product Classification

The FDA provides a classification database for public inquiry.

Product classification can be determined by querying the database of registered product information.

(4) FDA 510(k) Exempt Registration, Required Documents:

1. Application form

2. U.S. Agent

3. Product name and product code (if applicable)

Note: Models cannot be listed separately and must be included in the product name.

(5) FDA Medical Product Registration Annual Fee Payment

An annual fee must be paid to the FDA each year. The fee amount varies annually and is subject to FDA announcements.

If a product is no longer sold in the U.S., the annual fee does not need to be paid.

The completion time for registration depends on the processing period after the annual fee is received.

FDA medical device annual fees for the following year are renewed between October 1 and December 31 each year. Thus, October 1 also marks the start of the new FDA medical device product registration year.

(6) FDA Medical Product Registration Query Link:

Enter the corresponding Owner/Operator Number on the FDA website’s relevant page to query.

The Registration or FEI Number is assigned by the FDA 30-90 days after registration is completed.

(7) Precautions

Regardless of registration status, the FDA logo must not be used on products.

The FDA is not a certification mark or a certification body; it is the U.S. Food and Drug Administration.