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CDRH Portal Enhancements Allow Users to Submit Small Business Determination Requests and Track Premarket Approval Applications Online

The process for submitting a Small Business Determination (SBD) request and tracking medical device Premarket approval (PMA) applications and PMA Panel-Track supplements is getting easier. The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has updated the Customer Collaboration Portal (commonly called the CDRH Portal) to provide a centralized, self-service touchpoint for customers.

Check out what’s new:

• Small Business Determination (SBD) Program - Transition to Electronic Submission
  • On Oct. 1, 2024, SBD requests (Form 3602 and Form 3602A, and other related documents) may be submitted electronically through the CDRH Portal.
  • Starting Nov. 1, 2024, all SBD requests must be submitted electronically through the CDRH Portal.
• Premarket Approval (PMA) - Application Status
  • PMA applications and PMA Panel-Track supplements can now be tracked in the CDRH Portal. Users can view their application status in near real-time and review milestones.

These CDRH Portal updates are the latest steps in meeting the Medical Device User Fee Amendments 2022 (MDUFA V) commitments of using technology to enhance efficiency and transparency in reviewing medical device industry submissions. 

Questions?

Please contact the Division of Industry and Consumer Education.