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:

        Device Submissions for CBER-Regulated Products

Premarket Notification 510(k) Process for CBER-Regulated Products Home
          Vaccines, Blood & Biologics
          Development & Approval Process (CBER)
          Device Submissions for CBER-Regulated Products
          Premarket Notification 510(k) Process for CBER-Regulated ProductsDevice Submissions for CBER-Regulated Products Premarket Notification 510(k) Process for CBER-Regulated Products
  	
        Subscribe to Email Updates
    Share
    Post
    Linkedin

    Email
    PrintCenter for Biologics Evaluation and Research (CBER) regulates medical devices related to licensed blood and cellular products while applying appropriate medical device laws and regulations. The medical devices regulated by CBER are intimately associated with the blood collection and processing procedures as well as the cellular therapies regulated by CBER.

Jurisdiction of medical device review by the CBER is listed at Devices Regulated by the Center for Biologics Evaluation and Research | FDA

**Please do not send CBER device applications to the Center for Devices and Radiological Health (CDRH). All CBER device applications must be submitted in accordance with the**CBER Regulatory Submissions - Electronic and Paper website**information**.

**What are 510(k)s?**

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device (section 513(i)(1)(A) FD&C Act). Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalence claims. A legally marketed device is a device that was legally marketed prior to May 28, 1976 (pre- amendments device), or a device which has been reclassified from Class III to Class II or I, a device which has been found SE through the 510(k) process, or a device that was granted marketing authorization via the De Novo classification process under section 513(f)(2) of the FD&C Act that is not exempt from premarket notification requirements. The legally marketed device(s) to which equivalence is drawn is commonly known as the "predicate." Although devices recently cleared under 510(k) are often selected as the predicate to which equivalence is claimed, any legally marketed device may be used as a predicate. Legally marketed also means that the predicate cannot be one that is in violation of the FD&C Act.

Until the submitter receives an order declaring a device SE, the submitter may not proceed to market the device. Once the device is determined to be SE, it can then be marketed in the U.S. The SE determination is usually made within 90 days and is made based on the information submitted by the submitter.

Please note that FDA does not typically perform 510(k) pre-clearance facility inspections. The submitter may market the device immediately after 510(k) clearance is granted. The manufacturer should be prepared for an FDA quality system (21 CFR 820) inspection at any time after 510(k) clearance.

**Preparing a Premarket Submission**

The FDA has developed several different types of resources to help you prepare a premarket submission. These include the following:

CDRH Learn: A video-based series of teaching modules, seminars, and recorded webinars that cover a variety of policy and guidance efforts.
	FDA’s Q-Submission Program: Prospective applicants of future premarket submissions may request feedback from the FDA through a Pre-Submission, which is part of the Q-Submission Program. Information about this program may be found in the FDA guidance Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. We encourage you to read our online information and other available resources prior to sending any request for feedback.
	FDA Breakthrough Devices Program: This voluntary program helps patients have more timely access to certain medical devices that treat or diagnose a life-threatening or irreversibly debilitating condition by speeding up their development, assessment, and review. Devices subject to Premarket Approval applications (PMAs), premarket notifications [510(k)], or De Novo classification requests may be eligible. Sponsors can send a Breakthrough Designation request for their device at any time prior to sending the device’s marketing submission.**Premarket Notification 510(k) Resources**

Overview on Premarket Notification 510(k)

	What is Substantial Equivalence?
	Information on 510(k) Submission Process
	How to Find and Effectively Use Predicate Devices
		How to Prepare a Traditional 510(k)
		How to Prepare a Special 510(k)
		How to Prepare an Abbreviated 510(k)
		Is a new 510(k) required for a modification to the device?
	FDA Forms**CBER Approved Products**

Substantially Equivalent 510(k) Device Information
	Premarket Approvals and Humanitarian Device Exemptions with Supporting Documents
	Evaluation of Automatic Class III Designation (De Novo) Summaries (CBER)
	Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays
	Testing Human Cells, Tissues, and Cellular and Tissue Based Product (HCT/P) Donors for Relevant Communicable Disease Agents and Diseases**Guidance Documents**

The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]
	Format for Traditional and Abbreviated 510(k)s
	The Special 510(k) Program
	The Abbreviated 510(k) Program
	Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
	eCopy Program for Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff
	Refuse to Accept Policy for 510(k)s
	User Fees and Refunds for Premarket Notification Submissions (510(k)s)
	Deciding When to Submit a 510(k) for a Change to an Existing Device
	Deciding When to Submit a 510(k) for a Software Change to an Existing DeviceSub-Topic Paragraphs
          Follow CBER
		Division of Communication and Consumer Affairs
			Office of Communication, Outreach and Development
			Center for Biologics Evaluation and Research
			Food and Drug Administration
			10903 New Hampshire Ave WO71-3103
			Silver Spring, MD 20993-0002
		
		ocod@fda.hhs.gov
		
		(800) 835-4709
			(240) 402-8010
		
		For Updates on Twitter, follow @fdacber
	Resources for You (Biologics)
			About the Center for Biologics Evaluation and Research (CBER)
			Report a Problem to the Center for Biologics Evaluation & Research
			Recalls (Biologics)
			CBER-Regulated Products: Shortages and Discontinuations
			Biologics Products & Establishments

                                                                                  Content current as of:
      01/18/2022
                  
                   
Regulated Product(s)
		 BiologicsPremarket Notification 510(k) Process for CBER-Regulated Products
 Subscribe for CBER Updates
                        Get e-mail updates on What’s New at CBER!
    Enter your email address to subscribe:
 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