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U.S. FDA Medical Device Hydrogel Wound Dressing Requirements

FDA Medical Device Definition: A hydrogel wound dressing is a sterile or non-sterile device intended to cover a wound, to absorb wound exudate, to control bleeding or fluid loss, and to protect against abrasion, friction, desiccation, and contamination. It consists of a nonresorbable matrix made of hydrophilic polymers or other material in combination with water (at least 50 percent) and capable of absorbing exudate. This classification does not include a hydrogel 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 Hydrogel Wound Dressing companies with:

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