Frequently asked questions about the FDA approval process

The U.S. Food and Drug Administration is the governing body responsible for ensuring that foods, not including meat, poultry and some egg products, are safe, sanitary and properly labelled. These safety requirements also extend to cosmetics, dietary supplements and tobacco, among other things.

Frequently asked questions about the FDA approval process

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But what goes into these approval processes? How do you even apply to get your product approved? Specifically, what goes into the FDA’s drug approval processes? It is obviously essential that all drugs intended for human use are evaluated efficiently to ensure that they are safe. But what goes into this and how long does it take to get approved?

Application Processes

First and foremost, it is the responsibility of the company producing the drugs to ensure that they are tested properly. Clinical trials must be performed and supplied to the FDA to enable them to come to a decision as to whether the drug should be approved for marketing. Applications are usually processed within 10 months for a standard review and within six months for a priority review.

However, it is not just drugs that need the approval. Certain machines used in relation to drugs and other medical procedures also need approval. This is done via a 510k clearance, which notifies the FDA that a company wishes to register to tell them that they plan to market a medical device. This must be done at least 90 days in advance.

Companies such as are on hand to help clients through the processes of submitting a successful 510k. But how long does it take to get a FDA 510k approved?

Turnaround Time

Well Emergo, a global medical device regulatory consulting company based in the UK and set up in 1997 to assist US medical device companies export their goods to Europe successfully, has carried out many surveys detailing different time frames over the year. They then created a special 510k approximate turnaround calculator to help you estimate how long your application will take for your product code.

So if you are about to submit your 510k to the FDA, there are certainly the resources out there to assist you with your application, as well as help to ensure swift approval. Preparation, research and third-party guidance are definitely the keys to a successful process via the FDA approval system.

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