U.S. FDA Medical Device Nipple Shield Requirements
FDA Medical Device Definition: A nipple shield is a device consisting of a cover used to protect the nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk.
FDA Nipple Shield Label Requirements and Exceptions
FDA Nipple Shield Import Information
FDA Nipple Shield Detentions (Nipple Shield Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Nipple Shield Manufacturers (Nipple Shield Suppliers)
- Nipple Shield Distributors
- Nipple Shield Processors
- Nipple Shield Repackers
- Nipple Shield Relabelers
- Nipple Shield Exporters
- Nipple Shield Importers
For more information about Nipple Shield Medical Devices, simply click below:
U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
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