![]() Answer to the third question about private labeled devices Therefore, even if the distributor with a private label agreement is identified as the “complaint file establishment,” the OEM will still need to obtain copies of the complaint information from the distributor, and determine if medical device reporting and/or corrections and removals are required (i.e., recalls). Therefore, the OEM will be responsible for reporting and execution of recalls. In this situation, the OEM is the specification developer, as defined by the FDA. The quality agreement must specify which company is responsible for complaint handling ( 21 CFR 820.198) and medical device reporting (21 CFR 803). Answer to the second question about private labeled devices You will need a quality agreement defining the roles and responsibilities of each party, but that is all. There is no approval required by the FDA. If the OEM is outside the USA, then the distributor must register and list with the FDA as the initial importer and reference the K number when they complete the FDA listing. However, the OEM must be registered and listed with the FDA. The manufacturer is not required to be identified on the label. ![]() Therefore, if Joe Hage were the distributor, and you were the manufacturer, there are two legal options for the private labeled device: 1) “Distributed by Joe Hage”, or 2) “Manufactured for Joe Hage.” The FDA is unique in that they allow either the distributor or the manufacturer to be identified on the label, but both are not required. How can our distribution company avoid paying the FDA user fee?Īnswer to the first question about private labeled devices.What is the process to get this private label for the Class II device?.Who is responsible for complaint handling and medical device reporting? OEM or private-labeled distributor?.Is it legal to eliminate all mention of the OEM from the device labeling?.There will be no change to the indications for use. The OEM has 510(k) clearance, and the only product change will be the company’s name and address on the label. Our distribution company is interested in getting a private labeled devices agreement with an OEM to sell a Class II medical device in the USA. Questions about the private labeled devices process for FDA Devices that fall into the third category will subsequently fall into category 1 or 2 after the FDA approves the classification request. All other devices fall into one of three categories: 1) 510k exempt, 2) 510k cleared, or 3) De Novoclassification request approved. It is also important to remember that the FDA only approves devices through the pre-market approval (PMA) pathway. In contrast, most other countries have “own-brand labeling” regulations or regulations for private labeling devices. The reason for this is because the FDA regulations for devices allow for the labeling to identify the distributor only-without any mention of the OEM manufacturer on the label. Companies often ask about how to private labeled devices in the USA, because they are unable to find anywhere in the FDA regulations where private labeling of the device is described. This article was initially inspired by a question asked on the Medical Devices Group website hosted by Joe Hage.
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