The webinar, hosted by Rook Quality Systems and QuickVault by Veeva, focused on simplifying MedTech regulatory submissions. The event was moderated by Tory Lopez and featured speakers Jeff Hau, Axel Strombergsson, and Kyle Rose, who provided insights into five common medical device regulatory submissions: FDA 510(k), De Novo classification, PMA, CE Mark, and FDA pre-submission.
- The 510(k) regulatory pathway is most commonly used for Class II devices and some Class I devices, involving a comparison to a predicate device and performance testing.
- The De Novo classification is used for novel devices without a predicate, requiring a risk-benefit analysis and proposed special controls.
- Premarket Approval (PMA) is required for high-risk Class III devices, necessitating extensive testing and clinical trials.
- CE Marking is required for medical devices entering the EU market, and includes device description, quality management system auditing, technical documentation, and clinical evaluation reports.
- FDA Pre-submission is a free process for obtaining early feedback from the FDA, helping to de-risk regulatory strategies and clarify testing requirements.
The webinar presenters discussed strategies for successful submissions and timely market entry, emphasizing the importance of thorough planning, documentation, and leveraging digital tools like QuickVault’s eQMS software to manage submissions and streamline the process, ensuring efficiency and minimizing errors.
