The following are examples of when a 510(k) is not required.
- You sell unfinished devices to another firm for further processing or sell components to be used in the assembling of devices by other firms. A 510(k) is required, however, if your components are to be sold directly to end users as replacement parts.
- Your device is not being marketed or commercially distributed. You do not need a 510(k) to develop, evaluate, or test a device. This includes clinical evaluation. Please note that if you perform clinical trials with your device, you are subject to the Investigational Device Exemption (IDE) regulation (discussed below).
- You distribute another firm’s device and it is made in the U.S. Assuming the manufacturer has obtained a 510(k), you may place a label on the device, “Distributed by ABC Firm” or “Manufactured for ABC Firm,” and sell it to end users without submission of your own 510(k).
- In most cases, if you are a repackager or a relabeler, you are not required to submit a 510(k) if the existing labeling or condition of the device is not significantly changed. The labeling should be consistent with the labeling submitted in the 510(k) with the same indications for use and warnings and contraindications.
- Your device was lawfully marketed in the U.S. before May 28, 1976, and you have documentation to prove this. These devices are “grandfathered.” You do not have to submit a 510(k) unless the device has been significantly modified or there has been a change in its intended use.
- The device is made outside the U.S. and you are an importer of the foreign-made medical device. A 510(k) is not required if the foreign manufacturer submitted a 510(k) and received marketing clearance.
- Your device is exempted from 510(k) by regulation (21 CFR 862-892). That is, certain Class I or II devices can be marketed for the first time without having to submit a 510(k). A 510(k) is required, however, if the device exceeds the limitations of exemptions noted in chapters that end in .9 of the device classification regulations (e.g., 21 CFR 862.9, 21 CFR 864.9), such as the device has a new intended use or operates using a different fundamental scientific technology than a legally marketed device in that generic type of device, or the device is a reprocessed single-use device.
