The first step to ensure a successful FDA 510(k) submission is to perform a pre 510(k) gap analysis. During this phase our 510k consultants evaluate the classification of your medical device and determine the appropriate FDA product code and FDA regulation number.

In this preparation phase our 510k consultants determine which predicate devices already have FDA 510(k) clearance and whether they are appropriate for use in your medical device 510(k) submission.

Upon review of testing requirements, applicable FDA guidance documents and required standards, ISOplan USA will provide a detailed list of documents, diagrams, reports and clinical data necessary for FDA 510(k) preparation.

Of course our 510k consultants will need your input to prepare a technical comparison of your Class II medical device to other FDA 510(k) cleared predicate devices.

ISOplan USA will then provide you a detailed gap analysis report showing which information you already have and which data will be necessary for a successful submission.

Once the gap analysis has been performed you will be able to identify exactly which information is needed for your FDA 510(k) submission.

In this phase our 510k consultants can help you to identify any medical device specific guidance documents from the FDA, as well as general guidance for any required biocompatibility testing and software validation. Our FDA 510k consultants can also assist you in the development of labeling, including user manuals, which meet FDA regulatory requirements.

Additionally ISOplan USA can help you to identify the relevant design control requirements of the FDA Quality System Regulation (QSR), which will be required in the FDA 510k submission.

In the final phase our FDA 510k consultants will actually prepare on your behalf all 21 sections of your 510(k) application, coordinate your payment of FDA fees and submit the 510(k) to the US Food and Drug Administration.

Of course ISOplan USA be available as your FDA consultant to answer follow-up questions from the FDA reviewer.

Once your medical device has been cleared by FDA, our FDA 510k consultants will guide you through the FDA Establishment Registration and FDA Medical Device Listing.

Please note that under the FDA 510(k) premarket notification process, FDA gives clearance to medical devices to be sold in the US market; FDA does not give approvals to medical devices. Sometimes as FDA 510k consultants, we use the term “FDA 510k approval” for simplicity.

ISOplan USA medical device consultants have successfully prepared FDA 510(k) submissions for medical device and IVD (In Vitro Diagnostics) companies worldwide.

As FDA 510k consultants we can file an FDA 510(k) submission for your Class II medical device or IVD (In Vitro Diagnostics) with the Food and Drug Administration.

What is an FDA 510k?

A 510(k) is a premarket notification submission made to FDA to demonstrate that the medical device to be marketed is at least as safe and effective, that is ‘substantially equivalent’ (SE), to another medical device (predicate device) legally marketed in the USA.

ISOplanUSA can help you to collect and prepare the supporting documentation which compares your medical device to one or more similar legally marketed medical devices (predicate devices) and then make and support your substantial equivalency claims.

Substantial equivalence (SE) means that the new medical device is at least as safe and effective as the predicate device.

A medical device cannot be marketed in the U.S.A. until the submitter receives a clearance letter by FDA declaring the medical device is substantially equivalent to the predicate device.

Who must submit a FDA 510k Premarket Notification?

Medical device manufacturers or distributors introducing Class II medical devices to the US market must submit a 510(k) to the FDA.

An FDA 510(k) is also required for manufacturers changing the intended use of their medical device, or changing the technology of an FDA approved medical device in such a way that it may significantly affect the device’s safety or effectiveness. See Special FDA 510(k).

ISOplanUSA can assist you in understanding U.S. FDA submission documentation requirements, developing a Traditional 510(k), an Abbreviated 510(k) or a Special 510(k) submission which meets FDA expectations.

How to submit a FDA 510k?

If you think that your medical device is similar to others already marketed in the USA, ISOplan USA can help.  After confirming the product is either a Class II medical device or a Class I medical device that is not exempt from the premarket notification requirements, ISOplan USA can assist you in the filing of an FDA 510(k) submission.