What are FDA 510k clearances?

The Food and Drug Administration (FDA) is a US government body that takes ownership of protecting public health in America. It does this by ensuring that certain products are safe, secure and effective for human and animal use alike – primarily drugs, medical devices, food and veterinary products. It also takes ownership of approving any radiation-emitting products.


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When businesses are manufacturing products to sell within the US, they need to go through FDA processes. Typically, they will ask how long does it take to get a FDA 510k approved; of course, there are clear processes to work through to achieve this.

What is the 510k?

The 510k is a submission made to the FDA before a product can be taken to market in the US. It must demonstrate that the product that will be marketed to American consumers is ‘substantially equivalent’ – just as effective and safe, if not more so – to a similar product that has already been approved for sale on the market.

The process

How long does it take to get a FDA 510k approved? The Food, Drug and Cosmetic Act says that manufacturers of devices subject to FDA approval must register with the body and submit notification of their intention to market a food or medical device at least 90 days beforehand. This stage is the pre-market notification (PMN), which is also referred to as the 510k in reference to the section of the act it sits under.

The FDA will then assess the product and decide whether it is adequately equivalent to a pre-approved product already on the market; any new products that are entirely new to the market are assessed on their own merit. Manufacturers who are planning to adjust an existing approved product will also have to go through the same clearance process to have the modification approved to ensure it does not affect the product’s effectiveness or safety. This change could be a material change, a design change or a chemical composition change. It could also relate to the intended usage or the manufacturing process and energy source.

The FDA publishes a list of 510k approvals that it has cleared for marketing and distribution on its website every month, which other manufacturers can use as a reference starting point for their own approval process.

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