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U.S. FDA Medical Device Infusion Pump Requirements: Infusion Pump

FDA Medical Device Definition: An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm

Registrar Corp assists Infusion Pump companies with:

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

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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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