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U.S. FDA Medical Device Injection Cannula Requirements

FDA Medical Device Definition: An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

Registrar Corp assists Injection Cannula companies with:

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