The following seven examples illustrate when a 510(k) is not required.
1. If an unfinished device is to be sold to another firm for further processing, including components to be used in the assembling of devices by other firms. However, if components are to be sold directly to an end user as replacement parts, a 510(k) is required.
2. If the device is not being marketed or commercially distributed. A 510(k) is not needed to develop, evaluate, or test a device. This includes clinical evaluation. Note: if clinical trials are performed with your device, you may be subject to the provisions outlined in the Investigational Device Exemption (IDE) Regulation.53
3. If one distributes another firm’s domestically manufactured devices, there is no need to submit a 510(k). The device label should clearly communicate who the distributor is.
4. In most cases repackagers or relabelers are not required to submit a 510(k) if the existing labeling or condition of the device is not significantly changed.
5. If the device was legally in commercial distribution before May 28, 1976, a 510(k) submission is not required, unless the device has been modified, or there has been a change in its intended use. These devices are considered “grandfathered”.
6. If a foreign made medical device is imported, a 510(k) is not required if:
• a 510(k) has been submitted by the foreign manufacturer and received FDA marketing clearance, or
• a 510(k) has been submitted by an importer on behalf of the foreign manufacturer and has received FDA marketing clearance. If one importer submits a 510(k) on behalf of the foreign manufacturer, all other importers of that device, imported from the same foreign manufacturer (the 510(k) Holder) are not required to submit a 510(k) for ]that device.
7. If the device is exempted from this requirement by final classification regula – tion54 subject to the limitations on exemptions, it means certain Class I or II devices can be marketed for the first time without having to submit a 510(k).