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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. It does have oversight over pharmacy compounding of medications to protect patients' health.

Over-the-counter drugs, which do not need a prescription, must have FDA approval after a process called an OTC monograph.

OTC Monograph, Over-the-counter Drugs and Devices

The OTC monograph delineates the chemical structure of the drug, inactive ingredients like binders, labeling and dosage. A complete background on the drug is provided by the OTC monograph, which is also used by manufacturers who will make generic versions.

The FDA doesn't need to approve over-the-counter medical devices since these are usually low-risk, and are unlikely to pose serious risk even if they are not used properly.

This applies to adhesive bandages, braces, cold packs, heat packs and sport wraps. It also applies to items that aid in mobility such as canes, crutches and walkers.

Prescription Drugs and Devices

The FDA allows doctors to prescribe many drugs and devices "off-label" so these items are permitted to be prescribed for conditions that the FDA may not have given approval for if the doctor feels it is in the patient's best interest.

Always ask your doctor whether a drug or device is being used on-label or off-label when you are prescribed something new. This will allow you to have a clear understanding as to what risks you may be facing if your prescription is off-label.

Food for Humans and Animals

The FDA approves food for humans and animal feed, as well as food additives for both animals and human. The agency does not approve food labels, including Nutrition Facts, but does require factual nutritional information to go on most foods.

The agency does not approve pet food, but does approve additives in pet foods.

Cosmetics and Color Additives

The FDA does not approve cosmetics. This includes face and body cleansers perfume, hair dyes (except for those with coal tar), makeup, moisturizers, shampoos and products for shaving.

The FDA approves color additives in cosmetics, drugs, dietary supplements, some medical devices, as well as in food for humans and animals. Coal-tar hair dyes are exempt.

Companies, Facilities, Labs and Manufacturers

Food companies and cosmetic companies are inspected, imported food shipments are evaluated, samples are collected and analyzed. Any legal action is determined and carried out.

The FDA doesn't approve companies, health care facilities, laboratories or manufacturers. The agency does not develop or test items, but it does review testing by manufacturers.

The FDA inspects product manufacturers, ascertaining that their practices are within bounds. It reviews clinical testing and study results which have been carried out by manufacturers.

The agency ascertains that the trials meet appropriate standards and that any human participants are protected from unneeded risks.

FDA biologists, chemists, doctors and statisticians are some of the experts who evaluate the data. After this, the FDA determines whether or not to issue approval for the medication or device for a specific use.

Blood and tissue agencies must register with the FDA, as do owners and operators of domestic and foreign food, drug, and device facilites.

Mammography facilities need FDA certification, and they must have their certificates on display for patients.


What does “FDA approval” mean? Rotlaw.com. Retrieved Nov. 25, 2014.

What does it mean when FDA "clears" or "approves" a medical device? FDA.gov. Retrieved Nov. 25, 2014.

Is It Really FDA Approved? WebMD.com. Retrieved Nov. 25, 2014.

Reviewed November 26, 2014
by Michele Blacksberg RN

Visit Jody's website at http://www.ncubator.ca

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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.