What Does FDA-Approved Mean?
According to FDA, FDA-approved means the agency has reviewed a company's evidence and determined that a drug's benefits outweigh its risks for its intended use, or that a biological product is safe, pure and potent.[1] FDA-cleared means something different: through a 510(k), FDA found a device, usually a moderate-risk one, substantially equivalent to a device already legally on the market.[1][2]
Why FDA Approval Exists
With rare exceptions, new drugs and biological products must be FDA-approved before they are marketed, offered for sale or shipped between states.[1] To win approval, a company must show that its drug or biological product is safe and effective for the intended use and that the company can make it to federal quality standards.[1]
FDA does not develop products before approving them; FDA experts evaluate the results of the company's laboratory, animal and human testing.[1] FDA says "safe" does not mean a drug has no side effects; it means FDA has determined that the benefits of using the drug for a particular use outweigh the potential risks.[3]
Off-Label Use
FDA approval applies to a drug's intended use; when an approved drug is used for an unapproved use, FDA says it has not determined that the drug is safe and effective for that use.[1][3]
Off-Label Prescribing Explained
After Approval
FDA says it is impossible to have complete information about a drug's safety at the time of approval, so FDA keeps reviewing reports of problems after approval.[4] An Accelerated Approval can be withdrawn if follow-up trials fail to verify the drug's predicted clinical benefit.[5]
Generic Drugs and Biosimilars
FDA also approves generic drugs and biosimilar medicines.[1] Generic drug makers do not have to repeat clinical trials; instead, they run bioequivalence studies and file an Abbreviated New Drug Application with FDA.[4]
FDA-Approved vs. FDA-Cleared
FDA-cleared means something different: through a 510(k), FDA found a device, usually a moderate-risk one, substantially equivalent to a device already legally on the market.[1][2] Under federal regulations, a 510(k) clearance does not in any way denote official FDA approval of a device, and implying approval because of it is misleading.[6]
Device Risk Classes
FDA sorts medical devices into three risk classes: Class I includes the lowest-risk devices and Class III the highest-risk devices.[7]
| Class | Risk | Usual Route to Market |
|---|---|---|
| Class I | Lowest | Class I: general controls; most exempt from premarket notification |
| Class II | Moderate | Usually 510(k) clearance |
| Class III | Highest | Class III: premarket approval (PMA) |
Premarket Approval (PMA)
The highest-risk devices, Class III, generally need FDA approval of a premarket approval (PMA) application before they can be marketed.[1] FDA calls premarket approval its most stringent type of device marketing application.[8] FDA grants premarket approval when it determines that the application contains sufficient valid scientific evidence that the device is safe and effective for its intended use.[8]
510(k) Clearance
A 510(k) is a premarket submission that shows FDA a device is as safe and effective as, that is, substantially equivalent to, a device already legally on the market.[2] FDA considers a device substantially equivalent when it has the same intended use as the earlier device and either the same technology or different technology that does not raise different questions of safety and effectiveness.[2] Substantial equivalence does not require the new device to be identical to the earlier device.[2]
A 510(k) device may not be marketed in the U.S. until FDA sends a letter finding it substantially equivalent.[2] The performance data in a 510(k) can include clinical data as well as bench testing, such as engineering, sterility, software and biocompatibility testing.[2]
De Novo Classification
The De Novo pathway lets FDA classify a novel device that has no legally marketed predicate when general controls, or general and special controls, give reasonable assurance of safety and effectiveness.[9] Devices classified into Class I or Class II through a De Novo request may be marketed and may be used as predicates for future 510(k) submissions.[9]
Checking a Device's Record
Some older Class III device types that were on the market before the 1976 device amendments may still reach the market through a 510(k) if FDA has not called for premarket approval applications.[7] FDA keeps public 510(k) and premarket approval (PMA) databases that can be searched to check a device's FDA record.[10] We found no FDA source, among those reviewed for this page, that uses "cleared" for a drug; the sources use "approved" for drugs and "cleared" for devices that go through a 510(k).[1][2][5][6]
What FDA Does Not Approve
FDA says not all of the products it regulates go through premarket approval, which is a review of safety, quality and effectiveness by FDA experts before a product can be sold.[1] FDA does not approve health care providers, including physician offices and laboratories.[1]
FDA inspects manufacturing facilities but does not approve them independently of a product.[1] According to FDA, registering a facility or listing a drug or device with FDA does not mean FDA has approved the facility or the product, and does not mean the product may be legally marketed.[1] We found no FDA source, among those reviewed for this page, that treats FDA registration or listing as a sign of approval or quality.[1]
Mammography Facilities
Mammography facilities are a special case: they must be certified by FDA, or by a state approved by FDA as a certifier, and must display their certificates where patients can see them.[1]
Compounded Drugs
FDA says compounded drugs are not FDA-approved, and that FDA does not conduct a premarket review of their safety, effectiveness or quality.[1] By law, compounders do not need to prove to FDA that their products meet the same standards that drug manufacturers must meet.[1] FDA says a compounded drug and a generic drug are not the same: a generic drug is approved by FDA, while a compounded drug is not.[11]
FDA states: "Compounded drugs are not FDA-approved. This means that FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed."[11]
Compounded Medications Explained
Dietary Supplements
By law, FDA does not approve dietary supplements for safety and effectiveness, and FDA says many dietary supplements can be sold without even notifying FDA.[1] Supplement companies must notify FDA at least 75 days before marketing a supplement that contains certain new dietary ingredients, meaning ingredients not sold in the U.S. before Oct. 15, 1994.[1] Structure-function claims on dietary supplements carry a disclaimer that FDA has not evaluated the claim and that the product is not intended to diagnose, treat, cure or prevent any disease.[1]
Cosmetics and Medical Foods
Cosmetic products and ingredients, and their labeling, do not need FDA approval, except for color additives.[1] Medical foods do not go through FDA premarket approval.[1]
FDA's Logo
FDA says its logo should not be used to suggest that FDA endorses any private organization, product or service.[1]
Unapproved Prescription Drugs
FDA says unapproved prescription drugs pose significant risks because they have not been reviewed by FDA for safety, effectiveness or quality.[12] Without FDA review, FDA says there is no way to know whether an unapproved drug is safe and effective for its intended use, made to consistent quality, or labeled completely and accurately.[12]
FDA Terms at a Glance
The terms table summarizes how FDA describes each category, using FDA's own sources, and names no specific product.
| Term | What Is Reviewed Before Sale | Keep in Mind |
|---|---|---|
| FDA-approved drug | The company's evidence that the drug is safe and effective for its intended use, and its manufacturing quality | Not a promise of no side effects, and not a finding about other uses |
| Generic drug | Bioequivalence studies in an Abbreviated New Drug Application | Generic makers do not repeat the clinical trials |
| PMA-approved device | Sufficient valid scientific evidence that the device is safe and effective for its intended use | Covers the device's intended use |
| 510(k)-cleared device | Substantial equivalence to a device already legally on the market | Does not denote official FDA approval |
| De Novo-granted device | Whether general controls, or general and special controls, give reasonable assurance of safety and effectiveness | Once classified, the device may be marketed and may serve as a predicate for later 510(k)s |
| Compounded drug | No FDA premarket review of safety, effectiveness or quality | Not the same as a generic drug |
| Dietary supplement | No FDA approval for safety and effectiveness | Many can be sold without notifying FDA |
| FDA-registered facility or listed product | Registration or listing only | Does not denote approval, or that a product may be legally marketed |
| Unapproved prescription drug | Not reviewed by FDA for safety, effectiveness or quality | Without FDA review, there is no way to know safety, effectiveness or quality |
Sources: [1][2][4][6][8][9][11][12]
Related Reading
- FDA Drug Approval Process Explained
- Off-Label Prescribing Explained
- Compounded Medications Explained
- How We Grade Medical Evidence
- Is NAD+ IV Therapy FDA-Approved?
- Is Semaglutide FDA-Approved for Weight Loss?
References
- U.S. Food and Drug Administration. Is It Really 'FDA Approved'? fda.gov. FDA page content current as of 05/04/2026. https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved. Accessed 2026-09-28.
- U.S. Food and Drug Administration. Premarket Notification 510(k). fda.gov. FDA page content current as of 08/22/2024. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k. Accessed 2026-09-28.
- U.S. Food and Drug Administration. Understanding Unapproved Use of Approved Drugs 'Off Label'. fda.gov. FDA page content current as of 02/05/2018. https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label. Accessed 2026-09-28.
- U.S. Food and Drug Administration. Step 5: FDA Post-Market Drug Safety Monitoring. fda.gov. FDA page content current as of 01/04/2018. https://www.fda.gov/patients/drug-development-process/step-5-fda-post-market-drug-safety-monitoring. Accessed 2026-09-28.
- U.S. Food and Drug Administration. Development & Approval Process | Drugs. fda.gov. FDA page content current as of 08/08/2022. https://www.fda.gov/drugs/development-approval-process-drugs. Accessed 2026-09-28.
- 21 CFR 807.97, Misbranding by reference to premarket notification. Code of Federal Regulations, edition of April 1, 2025. govinfo.gov. https://www.govinfo.gov/content/pkg/CFR-2025-title21-vol8/xml/CFR-2025-title21-vol8-sec807-97.xml. Accessed 2026-09-28.
- U.S. Food and Drug Administration. Classify Your Medical Device. fda.gov. FDA page content current as of 08/26/2026. https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device. Accessed 2026-09-28.
- U.S. Food and Drug Administration. Premarket Approval (PMA). fda.gov. FDA page content current as of 05/16/2019. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-approval-pma. Accessed 2026-09-28.
- U.S. Food and Drug Administration. De Novo Classification Request. fda.gov. FDA page content current as of 09/30/2025. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request. Accessed 2026-09-28.
- U.S. Food and Drug Administration. Learn if a Medical Device Has Been Cleared by FDA for Marketing. fda.gov. FDA page content current as of 12/29/2017. https://www.fda.gov/medical-devices/consumers-medical-devices/learn-if-medical-device-has-been-cleared-fda-marketing. Accessed 2026-09-28.
- U.S. Food and Drug Administration. Compounding and the FDA: Questions and Answers. fda.gov. FDA page content current as of 09/16/2025. https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers. Accessed 2026-09-28.
- U.S. Food and Drug Administration. Unapproved Drugs. fda.gov. FDA page content current as of 05/09/2024. https://www.fda.gov/drugs/enforcement-activities-fda/unapproved-drugs. Accessed 2026-09-28.