Get the Medical Device Clearances and the Quality Systems You Need

If your device is intended to diagnosis a disease or other health conditions, or if your device is involved in the cure, mitigation, treatment, or prevention of disease, or if your device is intended to affect the structure or any function of the body, then your device is a medical device per Section 201(h) of the Food, Drug, and Cosmetic Act.

By this definition, a toothbrush is a medical device because it is intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.

You can check to see if your device is a medical device by searching FDA’s product classification database. A manual toothbrush has a product code of EFW.

The FDA considers a product to be a device, and subject to FDA regulation, if it meets the definition of a medical device per Section 201(h) of the Food, Drug, and Cosmetic Act.

Per Section 201(h) of the Food, Drug, and Cosmetic Act, a 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 Pharmacopoeia, 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 its primary intended purposes through chemical action within or on the body of man or other animals and which does not achieve 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 its primary intended purposes.

The Food and Drug Administration (FDA) has established three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. The three classes and the requirements which apply to them are:

Device Class and Regulatory Controls

1. Class I General Controls

-With Exemptions

-Without Exemptions

2. Class II General Controls and Special Controls

-With Exemptions

-Without Exemptions

3. Class III General Controls and Premarket Approval

The class to which your device is assigned determines, among other things, the type of premarketing submission/application required for FDA clearance to market. If your device is classified as Class I or II, and if it is not exempt, a 510(k) will be required for marketing. For Class III devices, a premarket approval application (PMA) will be required unless your device is a pre-amendments device (on the market prior to 1976). In that case, a 510(k) will be the route to market.

Vision28 can help you determine the class of your device and your path to market.

FDA identifies special testing for devices in their recognized consensus standards. You can search FDA’s consensus standards database for your product. For example, the recognized consensus standards for a manual toothbrush whose product code is EFW are:

ADA ANSI Standard No. 119-2015 Manual Toothbrushes

ISO 16409 Second edition 2016-10 Dentistry - Oral care products - Manual interdental brushes

ISO 28158 Second edition 2018-09 Dentistry - Integrated dental floss and handles