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U.S. FDA Medical Device Labeling Requirements

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Registrar Corp can assist you with U.S. FDA labeling requirements. Please complete the form below:

  I want to verify that my labeling meets current U.S. FDA requirements.
  I have a shipment detained due to labeling violations and need immediate assistance.
  I have not yet designed my product labeling and would like assistance.
Company Name: *
Contact Name: *
Contact Title: *
Facility Street Address: *
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Type of Business (Select all that apply): *
Contract Manufacturer - Manufactures a finished device in accordance with another establishment's specifications and puts the device in commercial distribution.
Contract Sterilizer - Provides a sterilization service for another establishment's devices and puts the devices in commercial distribution.
Initial Distributor/Importer - Takes first title to devices imported into the U.S. An Initial Distributor must have a U.S. address.
Manufacturer - Makes by chemical, physical, biological, or other procedures, any medical instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article.
Remanufacturer - Processes, conditions, renovates, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or in any way changes the intended use.
Repackager - Packages finished devices from bulk or repackages devices made by a manufacturer into different containers (excluding shipping containers).
Relabeler - Changes the content of the labeling from that supplied from the original manufacturer for distribution under the establishment's own name. A relabeler does not include establishments that do not change the original labeling but merely add their own name.
Reprocessor of Single Use Devices - Performs remanufacturing operations on a single use device.
Specification Developer - Develops specifications for a device that is distributed under the establishment's own name but performs no manufacturing. This includes establishments that, in addition to developing specifications, also arrange for the manufacturing of devices labeled with another establishment's name by a contract manufacturer.

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U.S. FDA Regulations:

U.S. FDA Medical Device Labeling: 21 C.F.R. sections 801.1 et seq.


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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