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.