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U.S. FDA Medical Device Hydrophilic Wound Dressing 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.

Registrar Corp assists Hydrophilic Wound Dressing companies with:

  • FDA Hydrophilic Wound Dressing Establishment Registration
  • FDA Hydrophilic Wound Dressing Listing
  • FDA Hydrophilic Wound Dressing Label Requirements and Exceptions
  • FDA Hydrophilic Wound Dressing Import Information
  • FDA Hydrophilic Wound Dressing Detentions (Hydrophilic Wound Dressing Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Hydrophilic Wound Dressing Manufacturers (Hydrophilic Wound Dressing Suppliers)
       - Hydrophilic Wound Dressing Distributors
       - Hydrophilic Wound Dressing Processors
       - Hydrophilic Wound Dressing Repackers
       - Hydrophilic Wound Dressing Relabelers
       - Hydrophilic Wound Dressing Exporters
       - Hydrophilic Wound Dressing Importers
For more information about Hydrophilic Wound Dressing Medical Devices, simply click below:






 
U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.


Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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