Detailed FDA classification of medical devices

There are more than 1,700 FDA medical device catalogues in the US. Depending on the level of risk, the FDA divides medical devices into three categories (I, II, III). The risk level increases step by step, and the category III risk level is the highest. The FDA clearly defines its product classification and management requirements for each medical device.

First, for any product, companies need to register for Enterprise Registration and Product Listing.

Class I device

General Control

Most products only need to be registered, listed, and implemented GMP specifications, and products can enter the US market (of which very few products are exempted from GMP, and very few products are required to submit 510(K) applications to PMM, PMN (Premarket Notification) ))

These devices can be used to ensure their efficacy and safety, such as crutches, ophthalmic lenses, and tapes, which account for about 27% of all medical equipment.

These controls include:

Sales of products that are shoddy and improperly labeled are prohibited;

The FDA may prohibit the sale of substandard products;

Must report the FDA regarding hazards, repairs, replacements, etc.;

Restrict the sale, sale, and use of certain equipment;

Implement GMP (Good Manufacturing Practice).

Class II products (about 46%)

General Control + Special Control

After the company registers and lists the products, in addition to the above general control, most of the products require pre-market notification (PMN: Premarket Notification) (ie 510K). A small number of Class II products can be exempt from the pre-market notification process. The manufacturer must submit an application to the FDA 90 days before the product is launched. After the 510K review, the product can be marketed.

Class III products (accounting for about 7%)

General Control + Premarket Approval (Premarket Approval)

After registration and listing, the company must implement GMP and submit a PMA application (some of the Class III products or PMN) to the FDA.

In general, Class III products are mostly equipment that maintains, supports life, or is implanted in the body. It is potentially dangerous to the patient and may cause injury or illness, such as heart rate regulators, intrauterine equipment, and baby incubators. 8% of all equipment. These equipment must be sold after the FDA's PMA has been obtained.

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Name	Maca Extract
Active Ingredient	Maca Extract
Appearance	powder
Grade	Food Grade
Storage	Cool Dry Place

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