U.S. FDA Medical Device Hydrophilic Beads Requirements
FDA Medical Device Definition: A hydrophilic wound dressing is a sterile or non-sterile device intended to cover a wound and to absorb exudate. It consists of nonresorbable materials with hydrophilic properties that are capable of absorbing exudate (e.g., cotton, cotton derivatives, alginates, dextran, and rayon). This classification does not include a hydrophilic wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.
FDA Hydrophilic Beads Label Requirements and Exceptions
FDA Hydrophilic Beads Import Information
FDA Hydrophilic Beads Detentions (Hydrophilic Beads Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Hydrophilic Beads Manufacturers (Hydrophilic Beads Suppliers)
- Hydrophilic Beads Distributors
- Hydrophilic Beads Processors
- Hydrophilic Beads Repackers
- Hydrophilic Beads Relabelers
- Hydrophilic Beads Exporters
- Hydrophilic Beads Importers
For more information about Hydrophilic Beads 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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