Registrar Corp

HomeMedical Devices510(k) Administrative ReviewMedical Device 510(k) Examples › U.S. FDA Iontophoresis Device Regulations

U.S. FDA Medical Device Iontophoresis Device Requirements: Iontophoresis Device

FDA Medical Device Definition: An iontophoresis device is a device that is intended to use a direct current to introduce ions of soluble salts or other drugs into the body and induce sweating for use in the diagnosis of cystic fibrosis or for other uses if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug. When used in the diagnosis of cystic fibrosis, the sweat is collected and its composition and weight are determined

Registrar Corp assists Iontophoresis Device companies with:

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

Live Help

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