Get 510 (K) medical devices registered with assistance from FDA expert. We help you by reviewing the whole testing requirements and going through FDA guidelines to meet the required standards.
A 510(k) is a Premarket Notification. It’s premarket submission to Food and Drug Administration (FDA) to demonstrate that the device is as safe and effective for human use as the legally marketed device that is not subjected to Pre-market Approval (PMA). The reason why a particular medical device is 510(k) is that 510(k) refers to section 510(k) of the Federal Food, Drug and Cosmetic Act (FD & C Act).
If you want to market Class I, Class II, and Class III devices in the US market for which a Premarket Approval application (PMA) is not required, you must submit US FDA 510 (k). Most of the Class I devices are excluded from 510k requirements. If the authority finds, during the review of the 510k file, that the device is Substantially Equivalent (SE), it will give clearance with a ‘k’ number. Meeting SE proves that the medical device is as safe and effective as the predicate device (legally marketed device in the USA).
Make 510(k) Medical Device Registration convenient and hassle-free with the help of former FDA officials at Quality Smart Solutions. We offer quality support to businesses in getting 510 K medical devices registered. We help:
Determine which predicate (similar) device already has FDA 510(K) clearance and whether it is suited for 510(k) submission.
Get help from our professionals in reviewing testing requirements, applicable FDA guidelines and documents and standards.
Get a detailed product-specific list of documents required for review from our FDA 510(k) consulting professionals.
We prepare and provide a complete list of reports, documents, diagrams or clinical data before 510(k) preparation begins.
With us, you can easily prepare a technical comparison of your medical device to other devices with FDA 510 (k) Clearance.
We interact with agencies during 510(k) Medical Device Registration process to get your medical devices registered.
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