Health and Fitness ? Food and Drug Administration ? Health and ...

The Food and Drug Administration, through its Code of Federal Regulations (CFR) in Title 21 requires that food, drugs, cosmetics, biologics, radiation-emitting electronic products, and medical devices comply with the labeling regulatory requirements. The general device labelling requirements are specified in part 801 of CFR 21.Some of other specific requirements are specified in detail in specific parts of CFR 21. They are:

1. In Vitro Diagnostic Products ? 21 CFR Part 809.
2. Investigational Device Exemptions ? 21 CFR Parts 812.
3. Good Manufacturing Practices ? 21 CFR Parts 820.
4. General Electronic Products ? 21 CFR Parts 1010.

Companies that do not meet the requirements of labeling as required by FDA will face action from FDA under the Federal Food, Drug and Cosmetic Act (FFDCA) that governs regulated products compliance.

General Device Labeling Requirements ? The minimum labeling requirements are as follows:

1. Name and place of business: The device shall contain the complete name and place of business of manufacturer, packer, or distributor and the information must be qualified by an appropriate statement.

2. Intended use: If the product is used by either the packer, seller or distributor for purposes other than those intended for by the manufacturer, adequate labeling must be provided.

3. Directions for use: Directions under which a layman can use the device safety must be provided on the label like the dosage, frequency, duration, method of application and any necessary preparations must be included.

Exemptions ? The exemptions are as under:

1. Prescription Device.
2. Retail Exemption.
3. Commonly Known Directions.
4. in Vitro Diagnostics.
5. Used in Manufacturing.
6. Used in Teaching, Research, or Law Enforcement.

Expiration of Exemptions:

The exemptions for the expire if they are used for purposes other than the exempted purposes.

Specific device labeling requirements ? The specific requirements for device labeling of the following are mentioned in separate sections of the title and need to be adhered to:

1. Denture repair kits.
2. Impact resistant lenses in sunglasses and eyeglasses.
3. Ozone emission levels.
4. Chlorofluorocarbon propellants.
5. Hearing aids.
6. Menstrual tampons.
7. Chlorofluorocarbons or other ozone depleting substances.
8. Latex Condoms.
9. Devices containing natural rubber.

Misbranding or false labelling:

If the?medical devices?labeling does not conform to the requirements and includes any false, misleading or objectionable labeling it is considered as misbranding for which action is taken for misbranding under the Federal Food, Drug and Cosmetic (FFD&C) Act.

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Source: http://medicaltips.biz/2011/09/23/food-and-drug-administration/

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