What does it mean for a product to
have FDA approval?
If a product has FDA approval (or in some cases FDA clearance),
it has met FDA's rigorous standards and may be sold legally
in the United States.
| How can I learn
if FDA has approved a particular drug or medical device?
You can search for FDA-approved drugs or medical devices
(including diagnostic tests) using two new FDA databases.
FDA's searchable web site of approved and tentatively approved
prescription, over-the-counter, and discontinued drugs.
FDA's searchable web site of cleared and approved medical
| How does FDA
evaluate new drugs?
FDA does not develop or test
new drugs. Instead, FDA gives advice and evaluates the data
submitted by manufacturers.
Before a new drug is sold in the U.S., it must have an approved
New Drug Approval (NDA) application.
The NDA includes the results of research done on the drug.
It must contain enough information for FDA reviewers to decide
- the drug is safe and effective in its proposed
use or uses,
- the benefits of the drug outweigh the risks,
- the drug's proposed labeling (package insert)
is appropriate, and
- the methods used to manufacture the drug
are adequate to preserve its identity, strength, quality,
Types of studies done on new drugs include:
- Animal studies - to see if a new drug will
be effective and adequately safe for human studies.
- Phase I clinical trials - to determine
drug safety. These are small studies, usually involving
20 to 80 subjects.
- Phase II clinical trials - to further explore
safety and to determine effective dosage for a specific
indication. These are larger studies, involving up to several
- Phase III clinical trials - to determine
the overall benefit-risk relationship of the drug and to
characterize the drug for its intended use. These studies
may involve up to several thousand subjects.
For more information about the drug approval process, see:
Test Tube To Patient: New Drug Development in the United States
| How does FDA evaluate
new medical devices?
FDA does not develop or
test new medical devices. Instead, FDA gives advice and evaluates
the data submitted by manufacturers.
Manufacturers wishing to sell any products that contain new
materials or differ in design from products already on the
market must submit a Premarket Approval (PMA) application
to FDA. A PMA must provide valid scientific evidence that
includes data from human subjects showing that the product
- effectively does what it claims to do,
- does not present any unreasonable risks
to the patient.
The majority of medical devices are cleared through the premarket
notification process (also called 510(k)), a less rigorous
process than the premarket approval process. Some devices
are exempt from both processes.
For more information about FDA's review of medical devices,
Device Advice: Overview of Regulations
| How can I find
more information on clinical trials?
For more information about clinical trials of new drugs and
medical devices, see:
| How can I find
out about problems with an FDA-approved product?
You can find out about recalls, safety alerts, and other
problems with FDA-approved products using FDA's databases
of safety information.
| How can I report
a problem with an FDA-approved product?
report a problem you have with an FDA-regulated product through
the MedWatch system.
For more information and instructions for reporting problems,
to Report Problems with Products Regulated by FDA
| How can I learn
about new drugs or medical devices before they receive FDA approval?
In most cases, FDA cannot give information about new drugs
or medical devices before they have received FDA approval.
You can learn about new products being developed by following
health news sources such as: