Use of Pre-Submission Pathways for Device Approvals
Use of Pre-Submission Pathways for Device Approvals Leveraging FDA Pre-Submission Pathways for Medical Device Approvals What Is the Pre-Submission (Q-Sub) Program? The FDA’s Pre-Submission program, often referred to as the Q-Submission or “Q-Sub” process, is a formal pathway that allows medical device sponsors to request feedback from the Center for Devices and Radiological Health (CDRH)…
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