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 In this section:

        Development & Approval Process (CBER)

Device Submissions for CBER-Regulated Products

                        
                


                Premarket Notification 510(k) Process for CBER-Regulated Products
          Investigational Device Exemptions (IDEs) for CBER-Regulated Products
          Premarket Approval (PMA) for CBER-Regulated Products Home
          Vaccines, Blood & Biologics
          Development & Approval Process (CBER)
          Device Submissions for CBER-Regulated ProductsDevelopment & Approval Process (CBER) Device Submissions for CBER-Regulated Products
  	
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    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 web page.



**Device Meetings**

In 2023, CBER staff transitioned to a hybrid workplace, with staff returning to work at the White Oak campus (on-site) for a portion of their time. This transition has enabled in-person face-to-face (FTF) formal meetings between FDA and industry to be restarted. To avoid overcrowding in the conference rooms, all in-person FTF formal meetings will have a hybrid component (virtual attendees in addition to in-person attendees). FDA will focus on having only core participants with a primary speaking role in-person while others join virtually. FDA encourages industry to follow this same pattern. To support hybrid meetings, FDA White Oak conference rooms are being upgraded, in phases, over the course of 2023 with new technology (e.g., noise-cancelling, boom-forming microphones, face/conversation tracking video cameras). The availability of hybrid conference rooms initially limits the number of in-person meeting requests that can be granted. Updates on CBER’s transition to in-person FTF formal meetings will be communicated in advance, including on this website.

Beginning August 7, 2023, CBER will begin the phased implementation of in-person (FTF) industry meetings with device manufacturers. At this time, CBER will limit in-person meetings to Submission Issue Requests (SIR).

CBER will continue to frequently monitor conference room upgrades, and as additional rooms are completed, we will continue the expansion until all formal meeting types that would qualify for FTF can be requested as in-person.


Sub-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:
      08/04/2023Device Submissions for CBER-Regulated Products                
                          

                        


                        Premarket Notification 510(k) Process for CBER-Regulated Products
          Investigational Device Exemptions (IDEs) for CBER-Regulated Products
          Premarket Approval (PMA) for CBER-Regulated Products
 
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