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  4. Formal Meetings and Requests for Feedback for CBER-Regulated Products
  1. Development & Approval Process (CBER)

Formal Meetings and Requests for Feedback for CBER-Regulated Products

The page serves as a resource for CBER stakeholders to find information on formal meetings, determine if a meeting with CBER needs to be requested, what type of meeting is appropriate, and how to submit your meeting request.

PDUFA Meetings

For products subject to the Prescription Drug User Fee Act (PDUFA), formal meetings between the Food and Drug Administration (FDA) and sponsors or applicants are a forum to discuss issues related to the development and review of FDA-regulated products. Meeting types and meeting formats are defined within the Definitions section of SOPP 8101.1.

Formal meetings can be conducted in person face-to-face, virtual face-to-face (video conference only), teleconference, and written response only (WRO).  All in person face-to-face meetings will have a virtual component. WRO can be requested and sent in lieu of holding a face-to-face (in-person or virtual) meeting or teleconference. CBER will make every effort to grant the requested format. CBER may determine a WRO to be appropriate for some meetings based on several factors. Considerations for converting meeting requests to a WRO are referenced within Appendix D of SOPP 8101.1. Meeting Management Procedural Goals can be found in tables within the Appendices of SOPP 8101.1.

NOTES:

  • Requestors are encouraged to submit meeting requests electronically via the FDA Electronic Submissions Gateway (ESG) to CBER for all CBER-regulated products.  
  • For CBER-regulated products that are not subject to PDUFA, the performance goals will not apply. CBER will make every effort to respond to meeting requests and meet with sponsors/applicants of non-user fee products as expeditiously as possible.

MDUFA Requests for Feedback

For products subject to Medical Device User Fee Act (MDUFA), submitters can request feedback in writing or a meeting with the Food and Drug Administration (FDA), through the Q-submission (Q-sub) program, regarding:

  • Potential or planned medical device Investigational Device Exemption (IDE) applications
  • Premarket Approval (PMA) applications
  • Humanitarian Device Exemption (HDE) applications
  • Evaluation of Automatic Class III Designations (De Novo requests)
  • Premarket Notification (510(k)) Submissions
  • Accessory Classification Requests 
  • Certain Investigational New Drug Applications (INDs) and Biologics License Applications (BLAs) submitted to the Center for Biologics Evaluation and Research (CBER)) (specifically, INDs and BLAs for devices that are regulated as biological products under section 351 of the Public Health Service (PHS) Act)

Please review guidance and FAQs below for information regarding the types of requests for information and meetings that are appropriate for your circumstance https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program.

Note for Combination Products: The type of meeting requested for a Combination Product depends on the primary mode of action. If the biologic/drug is the primary mode of action, please submit a meeting request per PDUFA, for devices, please submit your request per MDUFA.

 

 



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