Medical Devices | 510(K) Filings
For those medical devices for which special controls in device design, manufacturing, and use are necessary to ensure the devices can be used safely and effectively, a Premarket Notification (510(k) submission) is required. These medical devices typically represent moderate safety risks to patients and users. In the 510(k) filing process, the submitter must show that the subject device is substantially equivalent to a predicate device (a device that is already lawfully marketed in the U.S.).
Most Class 2 (and some Class 1 and Class 3) medical devices are subject to FDA’s 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). 510(k) submissions are required 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., when either the owner of an already cleared 510(k) changes the indication for use of the device, or when a 510(k) holder modifies a legally marketed device in a way that could significantly affect its safety or effectiveness.
FDAImports.com, LLC brings to your premarket notification process former FDA inspectors, compliance officers, FDA attorneys, and FDA medical device reviewers who understand the details of the process and the interests and concerns of the FDA. Finding The Way Through the premarket 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 FDAImports.com, LLC. for details on 510(k) preparation, filing and prosecution process for your medical device.