The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) and humanitarian device exemption applications (HDEs), that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the internet and the Agency's Dockets Management Staff.
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Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) and humanitarian device exemption applications (HDEs), that have been appro...
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83 FR 57730
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“Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications,” thefederalregister.org (November 16, 2018), https://thefederalregister.org/documents/2018-25071/medical-devices-availability-of-safety-and-effectiveness-summaries-for-premarket-approval-applications.