Registrar Corp

HomeMedical DevicesRegistration & Medical Device ListingsMedical Device Samples › U.S. FDA Occlusive Wound Dressing Regulations

U.S. FDA Medical Device Occlusive Wound Dressing Requirements


FDA Medical Device Definition: An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gases such as oxygen and water vapor through the device. It consists of a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing. This classification does not include an occlusive 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 Occlusive Wound Dressing companies with:

  • FDA Occlusive Wound Dressing Establishment Registration
  • FDA Occlusive Wound Dressing Listing
  • FDA Occlusive Wound Dressing Label Requirements and Exceptions
  • FDA Occlusive Wound Dressing Import Information
  • FDA Occlusive Wound Dressing Detentions (Occlusive Wound Dressing Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Occlusive Wound Dressing Manufacturers (Occlusive Wound Dressing Suppliers)
       - Occlusive Wound Dressing Distributors
       - Occlusive Wound Dressing Processors
       - Occlusive Wound Dressing Repackers
       - Occlusive Wound Dressing Relabelers
       - Occlusive Wound Dressing Exporters
       - Occlusive Wound Dressing Importers
For more information about Occlusive 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.
Home | About Us | News | Resources | Exhibitions | Seminars | Associations | Careers | Sitemap | Terms of Use © 2016 Registrar Corp
 
Food and Beverages | Drugs | Cosmetics | Medical Devices | Radiation-Emitting Electronic Devices | Color Additives | Tobacco