The FDA is modernizing the 510(k) framework to reflect advances in device technology, safety and capabilities, making it harder to obtain clearance.
If you’re used to basing substantial equivalence on older predicate devices, know this: the FDA now is looking for equivalence to a contemporary baseline of objective safety and performance criteria (think: interoperable, interconnected, more portable, automated, advanced materials…).
Do you know how to keep up with these developments?
Avoid the common mistakes many make with 510(k)s and adjust now to the FDA’s evolving expectations with this webinar.
Mary Vater, an experienced biomedical engineer serving as a medical device consultant specializing in regulatory affairs, will explain how to streamline your 510(k) processes and shorten your timeline to clearance. She’ll share current best practices and tips for submitting 510(k)s, the FDA’s changes and how to keep your 510(k)s on track.
- Specific changes the FDA made to the 510(k) process including implications for companies choosing predicates cleared more than a decade ago
- How to identify suitable and favorable predicate devices by identifying similar or competitor products and going beyond the premarket comparison
- How to determine what type of adverse events are common in your product classification so you can select a predicate with a relatively clean history
- How to deal effectively with new challenges, including the possible need for additional testing to reflect postmarket information for your device classification
- How to overcome specific challenges in creating and executing a sufficient test plan, including identifying all of the relevant standards and guidances and looking into the most recently cleared devices within your product code
- What the best time is to file your presubmission within the development process, and the right questions to ask to gain the most value from your meeting
- Understand and use third-party reviewers per the FDA’s new 510(k) Third Party Review Program issued in March
- How to stay current and find the latest FDA guidance and enforcement policies
It’s about to become even more of a challenge to obtain 510(k) clearances. Facilitate your 510(k)s and consolidate your timeline.
Who Will Benefit:
- Regulatory Affairs Specialists
- Medical Device Consultants
- Biomedical Engineers
- Research and Development Engineers