Department of Health and Human Services

Patient Network

Bringing Your Voice to Drug and Device Approval and Safety

Learn About Drug & Device Approval

The development of drugs and medical devices follows well-established paths to make sure that they are safe and effective when they reach the public. From concept to approval and beyond, FDA:

  • Reviews research data and information about drugs and devices before they become available to the public.
  • Watches for drug problems once drugs and devices are available to the public.
  • Monitors drug information and advertising.
  • Protects drug quality.

Drug and Device Development Processes

The development processes for drugs and devices are similar—each involves five basic steps. However, the processes differ within those steps. Click on either Drug Development or Device Development in the graphic below to learn more.

Step 1

Discovery/

Concept

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Discovery/Concept

Research for a new drug or device begins in the laboratory.

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Step 2

Preclinical Research

Preclinical Research

Drugs and devices undergo laboratory and animal testing to answer basic questions about safety.

Step 3

Clinical Research

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Clinical Research

Drugs and devices are tested on people to make sure they are safe and effective.

Step 4

FDA Review

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FDA Review

FDA review teams thoroughly examine all of the submitted data related to the drug or device and make a decision to approve or not to approve it.

Step 5

FDA Post-Market Safety Monitoring

FDA Post-Market Safety Monitoring

FDA monitors all drug and device safety once products are available for use by the public.