What are the minimal labeling requirements on the package of a Medical Device?

The minimal labeling requirements on the package label include:

1. Name and place of manufacturer, packer or distributor
2. Street address, city, state and zip code
3. Adequate directions for use

A prescription device is exempt from ‘adequate directions for use’, provided:

1. The device is in possession of a licensed practitioner
2. The labeling has an Rx statement
3. The labeling includes information for use
4. All labeling other than labels and cartons includes the date of issuance or date of the latest revision
5. Common use is known to the ordinary individual

The required information must be displayed prominently on the device label. Exemptions to prominence may be granted if device labeling lacks sufficient space. Labeling must be in English, and there are more specific labeling requirements for specific devices under 21 CFR 801.403.