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Day: May 9, 2024
Former FDA Reviewers: How to Avoid Missteps in STeP, Breakthrough Device Submission
May 9, 2024
Geographics
Medical device experts discussed at the 2024 RAPS Global Regulatory Strategy Conference how to submit materials for the FDA's Breakthrough Devices program and the Safety Technology Plan (STeP), as well as how to respond to deficiency letters.
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