U.S. FDA Medical Device Perineal Binder Requirements
FDA Medical Device Definition: A therapeutic medical binder is a device, usually made of cloth, that is intended for medical purposes and that can be secured by ties so that it supports the underlying part of the body or holds a dressing in place. This generic type of device includes the abdominal binder, breast binder, and perineal binder.
FDA Perineal Binder Label Requirements and Exceptions
FDA Perineal Binder Import Information
FDA Perineal Binder Detentions (Perineal Binder Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Perineal Binder Manufacturers (Perineal Binder Suppliers)
- Perineal Binder Distributors
- Perineal Binder Processors
- Perineal Binder Repackers
- Perineal Binder Relabelers
- Perineal Binder Exporters
- Perineal Binder Importers
For more information about Perineal Binder 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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