The Final Q-Sub Guidance provides comprehensive guidance on the Q-Sub process and finalizes the draft guidance regarding the Q-Sub program that was issued on March 15, 2024, with minimal changes from ...
On May 29, 2025, the U.S. Food and Drug Administration (FDA) issued a final version of its guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program,” ...
CTP Portal Next Generation also accepts Substantial Equivalence submissions. Step-by-step instructions on completing the forms; A more user-friendly interface that helps guide applicants through the ...
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