510k Submission

FDA 510k submission Process For Medical Device

• Anyone who wants to sell a medical device in the United States of America is required to make a FDA 510k submission at least 90 days before offering the device for sale, even though it may have been under development or clinical investigation before that date.
• A new FDA 510k submission is required for changes or modifications to an existing medical device. The amendments could significantly affect the safety or effectiveness of the device, or the device is to be marketed for a new or different indication for use.
• Change in the intended use for a device that you already have in commercial distribution. (Already cleared 510k submission process)
• If there is a change or modification of a legally marketed device, that change could significantly affect its safety or effectiveness.

US FDA 510k Number

US FDA 510k number is a premarket notification number provided by the FDA after a manufacturer or specification developer has demonstrated that the medical device is substantially equivalent in performance and safety to other devices already existing on the market.

An FDA 510k is not a premarket approval, neither establishment registration nor device listing.  In three situations, an FDA 510k is usually needed.

• The first is if it’s the first time bringing a new device to the market.
• The second is to change the indications for the use of a previously approved product,
• The third is to make significant changes to a previously approved device.

In these circumstances, you need 510k approval before you can register, list, or begin marketing.

Once determined, the appropriate device classification then needs to find the substantial equivalent device. Substantial Equivalence essentially proves that the current device, compared to a reference device, has the same intended use and technical characteristics or has the same planned application.

The technical variations do not pose any new concerns regarding safety and effectiveness.

Who should do the 510k submission?

• Domestic manufacturers are introducing a medical device to the U.S. market.
• Re-packer or Re-labeler who makes labelling changes or whose operations significantly affect the device.
• Foreign manufacturers/exporters or U.S. representatives of foreign manufacturers /exporters are introducing medical devices to the U.S. market.

When bringing a medical device to market in the United States, based on the risk class and intended use of the device to determine whether to (a) submit a premarket notification, also known as 510k, or (b) petition for premarket approval (PMA) exempted device. While these three terms may sound similar, the amount of time, money, and documentation involved with each are entirely different.

All these complexities necessities the importance of appointing a consultant or agent for various types of FDA 510k submissions.