FDA Cleared Vs FDA Approved: What’s The Difference?

In the United States, the Food and Drug Administration (FDA) is one of the big cheeses of public health, responsible for regulating a whole bunch of products that people use every day. These products are either “cleared” or “approved” (or neither) – but what do these terms actually mean? Is there any difference between the two?

The FDA can hand out clearances or approvals for all sorts of things, from certain food products and additives in cosmetics (although they do not approve cosmetics themselves) to drugs and biologics like vaccines. On the face of it, it would be easy to presume that there’s not much difference between a product being cleared or approved, but they are in fact distinct from one another.

Which process is required also depends on the product; all new human drugs and biologics have to go through approval, for example, whereas which process medical devices go through is dependent on their level of potential risk. Medical devices are split into three categories, with the highest risk (category 3) generally requiring approval, moderate-risk devices (category 2) generally needing clearance, and low-risk devices (category 1) needing neither.

FDA cleared

Gaining FDA clearance typically has the shortest timeframe out of the two – usually within 90 days of submission – primarily because it doesn’t involve as rigorous testing as approval. Rather than having to prove the safety and efficacy of the product itself, companies instead have to demonstrate that their product is “substantially equivalent” to an existing cleared or approved product.

The clearance process

Imagine you’re the creator of a new medical device (dream up whatever fantastical or incredibly boring thing you can). If it’s low-risk enough that you won’t need approval, this is the process you’ll have to go through:

1. Submit an application known as a 510(k) or premarket notification – the various parts of this submission “must compare their device to one or more similar legally marketed devices and make and support their substantial equivalence claims.”
2. The FDA conducts a review of the application, aiming to reach a decision within 90 days.
3. If deemed to be as safe and effective as the device it’s being compared to, the product is cleared and allowed to be marketed and sold in the US.

FDA approved

For high-risk (Class III) medical devices and new human drugs and biologics, manufacturers must acquire what’s known as “premarket approval”, which is a much longer and more stringent process.

According to the FDA, to gain approval, “a company must demonstrate that its drug or biological product is safe and effective for the intended use, and that it can manufacture the product to federal quality standards.”

The successful approval of a product means that the FDA has been satisfied by the safety and efficacy (the level to which a product achieves its desired result) evidence presented to it and that “the benefits of the product outweigh the risks for the intended use.”

The approval process

This time, let’s pretend you’ve developed a new drug (of the pharmaceutical kind, of course). By this point, you’ve hopefully already got several years’ worth of laboratory and animal testing (although maybe not the latter for much longer) under your belt.

Then it’s time to get the first of your FDA approvals from the Investigational New Drug process, which requires submission of study data so far (including any information about side effects in animals) and details on how you plan to conduct clinical trials.

If approved, you can merrily move on to clinical trials. If the data shows that the drug is safe and effective for its intended use, thus begins the next process – submitting a New Drug Application (NDA).

1. Submit the application. According to the FDA, this has to include everything there is to know about a drug, from evidence of its safety and efficacy in all stages of testing through to its proposed labeling.
2. The FDA reviews the evidence – if the application isn’t complete, it won’t be filed. If all is well, the agency begins evaluating if the drug is safe and effective for its intended use, whether its benefits outweigh the risks, its labeling, and the manufacturing process.
3. After between 6 and 10 months, the FDA makes its decision – if the evidence is sufficient, the drug is approved for marketing and being sold in the US.
4. Because there’s a limit to how much safety information you can glean before approval, the FDA will continue to monitor the drug once it’s on the market.

That’s a pretty long process, but there are certain circumstances under which it can be sped up, such as when it comes to products that can treat serious or life-threatening diseases – this occurs through the Accelerated Approval and Fast Track programs.

Emergency Use Authorizations (EUAs) can be given when “among other criteria, there are no adequate, approved, and available alternatives” based on the best currently available evidence – as was the case for some COVID-19 vaccines – and this process is different than standard FDA approval. As the FDA notes, these can be revoked or revised based on continued evaluation of available data.

The key differences

The details of the clearance and approval processes help in understanding how regulated products end up reaching the market, but if nothing else, these are the three key differences to take away:

• Time – approval usually takes an awful lot longer than getting clearance.
• Product type – some products have to go through the approval process, whereas others can instead be cleared.
• Level of scrutiny – clearance requires a product to be similar to an existing one, while approval needs years’ worth of supporting evidence.

All “explainer” articles are confirmed by fact checkers to be correct at time of publishing. Text, images, and links may be edited, removed, or added to at a later date to keep information current.  

The content of this article is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of qualified health providers with questions you may have regarding medical conditions.   

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