This presentation provides a comprehensive overview of the FDA’s medical device pre-submission process, a critical step for manufacturers seeking to efficiently bring safe and effective devices to market. This session will examine the strategic advantages of utilizing the pre-submission program (Q-Sub), outlining key components and benefits.
Events / Webinar
PDA Regulatory Conference 2025
Attend this webinar and learn:
- What regulatory changes could be coming in 2024
- FDA focal points in the new administration
- Potential impact to the MedTech and Pharm industries
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