The following are examples of when a 510(k) is not required. Selling unfinished equipment for further processing or selling to another company where components in the assembled equipment are to be used by another company. However, if your assembly is sold directly to the end user for replacement parts, a 510(k) is required. Your equipment is not being sold or commercially distributed. You do not need a 510(k) to develop, evaluate, or test the device. This includes clinical evaluations. Please note that if you conduct clinical trials with your device, you are subject to the Investigational Device Exemption (IDE) regulations (21 CFR 812). You are distributing another company's domestically produced device. You can place a label on the device, "Distributed by ABC Company" or "Manufactured by ABC Company" (21 CFR 801.1), and sell it to the end user without filing a 510(k). In most cases, if you are a repackager or relabeler you are not required to submit a 510(k) if the existing labeling or condition of the device has not changed significantly. The labeling should conform to the labeling submitted with the 510(k) using the same indications and warnings and contraindications. Your device was legally distributed commercially prior to May 28, 1976 and you have documentation to prove it. The devices are "grandfathered" and have Preamendment status. You do not have to file a 510(k) unless the device has been substantially modified or has reached a change in intended useable status. The device is imported from outside the U.S. and you are a foreign medical device. 510(k) is not required if a 510(k) has been submitted by the foreign manufacturer and a marketing authorization has been obtained. Once the foreign device manufacturer has received a 510(k) license, the foreign manufacturer may export his device to any U.S. importer. Your device is exempt from the 510(k) regulations (21 CFR 862-892). That is, certain Class I or II devices may be marketed for the first time without the need to file a 510(k). Medical device exemptions from 510(k) and GMP requirements can be found on the list of Class I and II exempt devices. However, if the device exceeds the limitations of the exemption in 0.9 of the device classification regulatory section (e.g., 21 CFR 862.9 864.9 21 CFR), such as if the device has a new proposed use or uses a different basic science or technology than that used in the operation of a legally marketed device, a generalized type of device, and the device is a reprocessed single-use device, then a 510(k) must be filed for the new device. to the market for a new device. Preamendment device
The term "preamendments device" means a device that was not lawfully marketed in the United States by a company prior to May 28, 1976 and: has been significantly altered or modified since that time; for which a provision requiring a PMA application has not yet been published by the FDA. FDA publication. Devices that meet the above criteria are called "grandfathered" devices and do not require a 510(k). The device must have the same intended use as one sold prior to May 28, 1976. If the device is labeled for a new proposed use, the device is considered a new device and a 510(K) must be submitted to FDA for marketing clearance.
Please note that you must have had the device on the market prior to May 28, 1976, with the device in its original condition. If your device is similar to a grandfathered device and was marketed after May 28, 1976, then your device does not meet the requirements for grandfathering and you must submit a 510(k). In order to make a firm claim that it has a preamendments equipment, it must prove that its equipment was typed, promoted, and distributed in interstate commerce for a specific intended use and that the intended use has not changed. See State Preamendment regarding documentation requirements.
Third Party Review Process
The Center for Devices and Radiological Health (CDRH) has implemented a third party review process. This program provides an option to submit their 510(k)'s to a private party (accredited third party) for review through the FDA, rather than submitting directly to certain device manufacturers identified by CDRH. For more information about the program, eligibility for accredited third party devices and a list of go to the Third Party Review Program information page.