Devices

CDRH Portal Update Tracks PMA Submissions

FDA has updated CDRH’s Customer Collaboration Portal to track the progress of PMA applications and accept Small Business Determination (SBD) requests.

An agency notice says CDRH’s portal can now track the progress of PMA applications and PMA Panel-Track supplements. “Users can view their application status in near real-time and review milestones,” it says.

The portal also now accepts SBD requests and it includes details about the process, according to the notice. Additional information about the small business eligibility and submission requirements is available on the Small Business Determination (SBD) Program Web page, it says.

The CDRH portal updates are part of the Medical Device User Fee Amendments 2022 commitments of using technology to improve efficiency and transparency in reviewing industry submissions. The notice states that a future update will allow IDEs to be tracked.

CDRH Portal Update Tracks PMA Submissions

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