Class I medical devices have the least amount of regulatory control. Class I devices present minimal potential harm to the user. These devices are typically simple in design and manufacture, and have a history of safe use and are only subject to general controls designed to achieve safety and effectiveness through the control of manufacturing, labeling, and related issues,2 0 including FDA’s Good Manufacturing Practices (GMP).2 1 Examples of Class I devices include tongue depressors, arm slings, bandages, manual and electric toothbrushes, examination gloves and hand-held surgical instruments.
General controls include:
1. Establishment Registration22 (FDA Form 289123) of companies which are required to register under 21 CFR §807.20, such as manufacturers, distributors, repackages, and relabelers. Foreign establishments, however, are not required to register their establishments with FDA.
2. Medical Device Listing24 (FDA Form 289213) with FDA for devices to be marketed.
3. Manufacturing devices in accordance with GMP25 in 21CFR §820.
4. Labeling26 devices in accordance with labeling regulations in 21CFR §801 or §809.
5. Submission of a premarket notification [510(k)], if applicable, before marketing a device.