Frequently Asked Questions

• What does it mean for a product to have FDA approval?
• How can I learn if FDA has approved a particular drug or medical device?
• How does FDA evaluate new drugs?
• How does FDA evaluate new medical devices?
• How can I find more information on clinical trials?
• How can I find out about problems with an FDA-approved product?
• How can I learn about new drugs or medical devices before they receive FDA approval?

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.

Back to Top

You can search for FDA-approved drugs or medical devices (including diagnostic tests) using two new FDA databases.

• Drugs@FDA
  FDA's searchable web site of approved and tentatively approved prescription, over-the-counter, and discontinued drugs. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/
  
• Devices@FDA
  FDA's searchable web site of cleared and approved medical devices. http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/

Back to Top

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 if:

• 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, and purity.

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 hundred subjects.
• 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:

From Test Tube To Patient: New Drug Development in the United States
http://www.fda.gov/fdac/special/testtubetopatient/

Back to Top

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, and
• 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, see:

FDA Device Advice: Overview of Regulations
http://www.fda.gov/cdrh/devadvice/overview.html

Back to Top

For more information about clinical trials of new drugs and medical devices, see:

ClinicalTrials.Gov
http://www.clinicaltrials.gov/

Back to Top

You can find out about recalls, safety alerts, and other problems with FDA-approved products using FDA's databases of safety information.

• Recent Recalls, Market Withdrawals and Safety Alerts
  List of the most significant product actions of the last 60 days, based on distribution and health risk. http://www.fda.gov/opacom/7alerts.html

 
• FDA Enforcement Report
  Index of actions taken in connection with agency regulatory activities.
  http://www.fda.gov/opacom/7alerts.html

 
• Manufacturer and User Facility Device Experience Database (MAUDE)
  Reports of medical devices which may have malfunctioned or caused deaths or serious injuries. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM

• Safety Alerts, Public Health Advisories and Notices from CDRH
  http://www.fda.gov/cdrh/safety.html

• Medical Device Safety
  http://www.fda.gov/cdrh/patientsafety/

• FDA Patient Safety News
  http://www.fda.gov/psn

Back to Top

You can report a problem you have with an FDA-regulated product through the MedWatch system.

For more information and instructions for reporting problems, see:

How to Report Problems with Products Regulated by FDA
http://www.fda.gov/opacom/backgrounders/problem.html

Back to Top

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:

• MedlinePlus Health Information
  http://www.medlineplus.gov/
   
• Healthfinder
  http://www.healthfinder.gov/

Back to Top