Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

        Learn About Drug and Device Approvals

The Device Development Process

                        
                Step 1: Device Discovery and Concept
          Step 2: Preclinical Research-Prototype
          Step 3: Pathway to Approval
          Step 4: FDA Device Review
          Step 5: FDA Post-Market Device Safety Monitoring Home
          For Patients
          Learn About Drug and Device Approvals
          The Device Development ProcessLearn About Drug and Device Approvals The Device Development Process
  	
        Share
    Post
    Linkedin

    Email
    Print**Step 1**
Device Discovery
and Concept
**Device Discovery and Concept**
Research for a new drug or device begins in the laboratory.More Information



**Step 2**
Preclinical Research
– Prototype

**Preclinical Research–Prototype**
Devices undergo laboratory and animal testing to answer basic questions about safety.More Information



**Step 3**
Pathway to Approval

**Pathway to Approval**
Devices are tested on people to make sure they are safe and effective.More Information



**Step 4**
FDA Review

**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.More Information



**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.More Information

                                                                                  Content current as of:
      01/04/2018The Device Development Process                
                          

                        Step 1: Device Discovery and Concept
          Step 2: Preclinical Research-Prototype
          Step 3: Pathway to Approval
          Step 4: FDA Device Review
          Step 5: FDA Post-Market Device Safety Monitoring
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop