U.S. FDA Medical Device Abdominal 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 Abdominal Binder Label Requirements and Exceptions
FDA Abdominal Binder Import Information
FDA Abdominal Binder Detentions (Abdominal Binder Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Abdominal Binder Manufacturers (Abdominal Binder Suppliers)
- Abdominal Binder Distributors
- Abdominal Binder Processors
- Abdominal Binder Repackers
- Abdominal Binder Relabelers
- Abdominal Binder Exporters
- Abdominal Binder Importers
For more information about Abdominal 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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