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