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Medical Devices FDA
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Medical Devices FDA
[FDA] General Device Labeling Requirements
- Admin Hits:581
- 2020-12-14 20:04:00
Name and Place of Business (21 CFR 801.1)
•The label of a device shall contain the name and place of business of manufacturer, packer, or distributor including the street address, city, state, and zip code.
•If the firm's street address is in the local telephone directory, the street address can be omitted.
•If the firm listed on the label is not the manufacturer, the firm information must be qualified by an appropriate statement such as, "Manufactured for..." or "Distributed by...."
Intended Use 21 CFR 801.4
•If a packer, distributor, or seller intends a device for uses other than those intended by the person from whom he received the device, these parties must furnish adequate labeling in accordance with the new intended use.
•If a manufacturer knows or has information indicating that this device is to be used for conditions or purposes other than which it was intended, he is required to provide adequate labeling in accordance with such other uses. (An example of this might be a manufacturer of dental X-ray equipment who is routinely selling his product to podiatrists.)
Adequate Directions 21 CFR 801.5
•"Adequate directions for use" means directions under which the layman can use a device safely and for the purposes intended. This includes:
oStatements of all purposes for which and conditions under which the device can be used;
oQuantity of dose for each use and usual quantities for persons of different ages and physical conditions;
oFrequency of administration;
oDuration of application;
oTime of administration in relation to other factors;
oRoute or method of application; and
oAny preparation necessary for use.
•The label of a device shall contain the name and place of business of manufacturer, packer, or distributor including the street address, city, state, and zip code.
•If the firm's street address is in the local telephone directory, the street address can be omitted.
•If the firm listed on the label is not the manufacturer, the firm information must be qualified by an appropriate statement such as, "Manufactured for..." or "Distributed by...."
Intended Use 21 CFR 801.4
•If a packer, distributor, or seller intends a device for uses other than those intended by the person from whom he received the device, these parties must furnish adequate labeling in accordance with the new intended use.
•If a manufacturer knows or has information indicating that this device is to be used for conditions or purposes other than which it was intended, he is required to provide adequate labeling in accordance with such other uses. (An example of this might be a manufacturer of dental X-ray equipment who is routinely selling his product to podiatrists.)
Adequate Directions 21 CFR 801.5
•"Adequate directions for use" means directions under which the layman can use a device safely and for the purposes intended. This includes:
oStatements of all purposes for which and conditions under which the device can be used;
oQuantity of dose for each use and usual quantities for persons of different ages and physical conditions;
oFrequency of administration;
oDuration of application;
oTime of administration in relation to other factors;
oRoute or method of application; and
oAny preparation necessary for use.
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