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FDA Approval: What Requires It, What Doesn't?

By HERWriter
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 FDA Approval: What Requires It, and What Doesn't? Yuri Vartanov/PhotoSpin

The U.S. Food and Drug Administration, also known as the FDA, plays an important role in so many aspects of our lives. "FDA approved" is a term we may all be familiar with. But do we know what it means?

Here is a look into several of the areas subject to FDA control, and several that are not regulated by the agency. Some of what you read may surprise you.

The FDA evaluates items for medical use such as appliances and medications. These are examined, tested and either approved or cleared.

To gain FDA approval, a drug or high-risk medical item must be seen to be safe and effective. This approval doesn't guarantee that the device or drug is free of all risk. Rather, approval indicates that the FDA has determined that its benefits outweigh any risks.

The FDA goes through a screening process that has three stages. This determines whether or not a medical item needs to be approved, and how involved the evaluation process for the item needs to be.

Medical Devices

The FDA approves medical devices.

High-risk devices require the highest evaluation level. This pertains to devices that are different from anything else currently on the market, as well as medical implants, mechanical heart valves and implantable infusion pumps.

Moderate-risk devices are summarily screened under section 510(k). This applies to devices similar to items that have previously been approved by the FDA, including dialysis equipment, and some catheters.

Low-risk devices do not require approval. This applies to over the-counter products like adhesive bandages.


The FDA approves or declines approval on new drugs, including biologics such as cellular and gene therapies, and vaccines.

FDA approval, and the need for it, is in part based on what a particular item is meant to cure, prevent or treat. So a drug may be approved for one condition but may not have approval for a different condition.

While the FDA may decide that the medication's benefit outweighs risk for one disease, this does not necessarily hold true for the other disease.

FDA doesn't approve compound drugs.

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We value and respect our HERWriters' experiences, but everyone is different. Many of our writers are speaking from personal experience, and what's worked for them may not work for you. Their articles are not a substitute for medical advice, although we hope you can gain knowledge from their insight.