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Posted On: 06/25/2024 10:07:06 AM
Post# of 495
Just to lay out the complete PMA process......
Overview
The review of a premarket approval application (PMA) is a four-step review process consisting of:
administrative and limited scientific review by FDA staff to determine completeness (acceptance and filing reviews);
in-depth scientific, regulatory, and Quality System review by appropriate FDA personnel (substantive review);
review and recommendation by the appropriate advisory committee (panel review); and final deliberations, documentation, and notification of the FDA decision.
https://www.fda.gov/medical-devices/premarket...ew-process
JMO all is well at UHP and Brian Thom & team are on it!!
Still buying!!
Overview
The review of a premarket approval application (PMA) is a four-step review process consisting of:
administrative and limited scientific review by FDA staff to determine completeness (acceptance and filing reviews);
in-depth scientific, regulatory, and Quality System review by appropriate FDA personnel (substantive review);
review and recommendation by the appropriate advisory committee (panel review); and final deliberations, documentation, and notification of the FDA decision.
https://www.fda.gov/medical-devices/premarket...ew-process
JMO all is well at UHP and Brian Thom & team are on it!!
Still buying!!
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