Medical Devices | 510(K) Filings

For those medical devices in which special controls in device design, manufacturing, and use are necessary to ensure the devices can be used safely and effectively, a Pre-Market Notification (PMN) or FDA 510(k) submission is required. These medical devices are of the type that represents moderate safety risks to patients and users. In the FDA 510(k) or PMN filing process, the medical device manufacturer or device distributor is required to show the medical device is substantially equivalent to a device that is already lawfully marketed in the U.S. under a valid, cleared 510(k) or it is substantially equivalent to a device that was lawfully marketed in the U.S. prior to May 28, 1976 (the date the Safe Medical Devices Act was enacted into law creating the PMN or 510(k) process).

Most Class 2 (and some Class 1 and Class 3) medical devices are subject to FDAs premarket notification (PMN) or 510(k)) submission process. Certain steps in the development and manufacturing process for medical devices trigger the requirement to prepare and file a 510(k) or PMN. For instance, you are required to submit a 510(k) when a foreign manufacturer intends to export a medical device to the U.S. that the firm has never before shipped to the U.S., or when either the owner of an already cleared 510(k) changes the intended uses of the device or a PMN or 510(k) holder modifies a legally marketed device in a way that could significantly affect its safety or effectiveness., LLC brings to your 510(k) or pre-market notification process former FDA inspectors, former FDA compliance officers, former FDA attorneys and former FDA medical device reviewers who understand the details of the process and the interests and concerns of the FDA. Finding The Way Through the 510(k) or pre-market notification process means the difference between successfully importing a medical device into the U.S. and an FDA import detention or FDA Import Alert or FDA import refusal of admission. Contact, LLC for details on the 510(k) or PMN preparation, filing and prosecution process for your medical device.