What does “FDA approval” mean?

The U.S. Food and Drug Administration (FDA) examines, tests, and approves a wide range of items for medical use, including drugs and medical appliances.  In the simplest terms, “FDA approval” means that the FDA has decided the benefits of the approved item outweigh the potential risks for the item’s planned use.

The FDA evaluates and approves many different things, including:

  • new drugs, including biologics,
  • food additives for people and animals,
  • color additives in food, drugs, and cosmetics for people and animals,
  • some medical devices.
The FDA uses a three-tier screening process to decide whether or not a medical device will require approval and how hard the FDA needs to look at the medical device before approving it.  For “high-risk” devices, including medical implants and devices unlike anything currently on the market, the FDA applies its highest level of evaluation.  For “moderate-risk” devices, including devices “substantially similar” to things already approved by the FDA, the FDA gives the item a summary screening under section 510(k).  For “low-risk” devices, like adhesive bandages and many other items sold over the counter, the FDA does not require approval at all.
How Does a Drug or Device Manufacturer Get “FDA Approval”?
In order to receive FDA approval for a drug or a high-risk medical device, a drug’s or device’s manufacturer must prove to the FDA that the item is “safe and effective.”  Although no drug or medical device is entirely risk-free, the research and testing must show that the benefits of the drug or device for a particular condition outweigh the risks to patients of using the item.
The FDA does not do its own testing of new drugs, medical devices, or other items.  Instead, it reviews the results of clinical testing and studies performed by the item’s manufacturer.  The FDA approval process requires the manufacturer to work with the FDA during human trials of drugs and other devices to ensure trials meet rigorous scientific standards and that human subjects are protected from unnecessary risks.  The FDA uses its own statisticians, biologists, chemists, physicians, and other experts to analyze the data from the manufacturer’s clinical trials and other research.  Based on this analysis, the agency decides whether or not to approve a drug or medical device for a particular use.
Do Over-the-Counter Drugs and Medical Devices Need FDA Approval?
Drugs sold over-the-counter (without a prescription) must be approved by the FDA to treat any condition the drug will be marketed to treat.  For instance, over-the-counter pain medications must be FDA-approved to treat pain.
To be approved for over-the-counter sale, a drug not only has to meet the FDA approval process requirements, but it must also fulfill an additional step known as an “OTC monograph.”  The FDA describes the OTC monograph as a kind of “recipe book” that explains the over-the-counter drug’s chemical structure, its inactive ingredients (such as binders that hold a pill together), doses, and labeling.  The OTC monograph provides a thorough background on the over-the-counter drug and is a crucial source of information for manufacturers who want to make generic versions of the same medication.
Medical devices sold over-the-counter generally are not approved by the FDA.  This is because most over-the-counter medical devices are deemed “low-risk,” or things that probably won’t cause life-threatening harm to a patient if used incorrectly.  Adhesive bandages, braces, sports wraps, cold packs, heat packs, and mobility devices like crutches, canes, and walkers are all examples of “low-risk” medical devices that can be sold over-the-counter without requiring FDA approval.
FDA Approval and Off-Label Use

When asking whether a drug or medical device is FDA-approved, it’s important to ask, “What is it FDA-approved for?”  FDA approval for medical items, including drugs, is based on what the item is going to be used to treat, cure, or prevent.

For instance, the FDA might approve a certain medication to treat high blood sugar associated with diabetes, because the FDA concluded that the benefits of using the medication to lower blood sugar in diabetes patients outweighed the risk the drug’s side effects could pose to patients taking it.  However, the FDA may not have approved the drug for use in treating high cholesterol, because its research did not find that the benefits outweighed the risks for cholesterol patients.

Most drugs and medical devices can be prescribed “off-label,” meaning they can be used to treat conditions that the FDA has not approved them to treat.  The FDA gives doctors this freedom because each patient has individual needs that may respond better to an off-label drug or device than to an on-label one.

However, when you are prescribed a new medication or device, it’s wise to ask whether the drug is being used on-label or off-label to treat your condition.  The risks of using an item off-label are higher because the item has not been specifically approved for an off-label use.  By talking to your doctor, you can learn more about the off-label risks of the particular drug or device and the benefits your doctor expects to gain by prescribing the off-label drug or device for your particular medical condition.

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