FDA Compliance - Techlink

Applying for Investigational Device Exemption Applications (IDEs)

In some risky cases such as but not limited to human study, you will need to obtain an Investigational Device Exemption (IDE) from the FDA.

This IDE must be submitted by the studies sponsor prior to the investigation of a medical device or before an IVD is initiated. The role of the IDE is for the FDA to approve the sponsor’s study application. It confirms compliance to all requirements of 21 CFR 812.

The first and most vital point of the sponsor’s study is to assess whether a medical device poses a significant risk insofar as the IDE Approval process is linked with the risk associated with the Medical Device or IVD. If a significant risk is detected, you will need approval from both the FDA and the Institutional Review Board (IRB) (which is not affiliated with the FDA) before the implementation of human study. If no significant risk is found, you will require IRG approval before the clinical study can take place. Please note that there are exceptions to the above rule as in some instances, devices with insignificant risks must comply with the requirements of devices with significant risks.

What Is Medical Device Listing

Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration.

Who Must List

Establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the United States (U.S.) are required to register annually with the FDA. Most establishments that are required to register are also required to list the devices and the activities performed on those devices at that establishment including devices imported to the US.

The following establishment types are required to list their devices:

Contract Manufacturer

Manufactures a finished device to another establishment’s specifications and places the device into commercial distribution.

Contract Sterilizer

Provides a sterilization service for another establishment’s devices and places the device into commercial distribution.


Makes by chemical, physical, biological, or other procedures, any article that meets the definition of “device” in section 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act.


Processes, conditions, renovates, repackages, 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 and/or Relabeler

Repackager: Packages finished devices from bulk or repackages devices made for the establishment 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.

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.

Foreign Exporter

Exports or offers for export to the United States, a device manufactured or processed by another individual, partnership, corporation or association in a foreign country.

Medical Devices Registration & Listing Exemptions

(a) A manufacturer of raw materials or components to be used in the manufacture or assembly of a device who would otherwise not be required to register under the provisions of this part.

(b) A manufacturer of devices to be used solely for veterinary purposes.

(c) A manufacturer of general purpose articles such as chemical reagents or laboratory equipment whose uses are generally known by persons trained in their use and which are not labeled or promoted for medical uses.

(d) Licensed practitioners, including physicians, dentists, and optometrists, who manufacture or otherwise alter devices solely for use in their practice.

(e) Pharmacies, surgical supply outlets, or other similar retail establishments making final delivery or sale to the ultimate user. This exemption also applies to a pharmacy or other similar retail establishment that purchases a device for subsequent distribution under its own name, e.g., a properly labeled health aid such as an elastic bandage or crutch, indicating “distributed by” or “manufactured for” followed by the name of the pharmacy.

(f) Persons who manufacture, prepare, propagate, compound, or process devices solely for use in research, teaching, or analysis and do not introduce such devices into commercial distribution.

(g) [Reserved]

(h) Carriers by reason of their receipt, carriage, holding or delivery of devices in the usual course of business as carriers.

(i) Persons who dispense devices to the ultimate consumer or whose major responsibility is to render a service necessary to provide the consumer (i.e., patient, physician, layman, etc.) with a device, or the benefits to be derived from the use of a device; for example, a hearing aid dispenser, optician, clinical laboratory, assembler of diagnostic x-ray systems, and personnel from a hospital, clinic, dental laboratory, orthotic or prosthetic retail facility, whose primary responsibility to the ultimate consumer is to dispense or provide a service through the use of a previously manufactured device.

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