FDA’s Plan for Modernizing the 510(k) Pathway – Webinar Recording/Transcript
The majority of medical device products are subject to the 510(k) clearance pathway, so, if you’re developing a device in the United States, the FDA’s proposed changes to the process likely apply to you. Are you ready for these adjustments?
This presentation on the FDA’s Plan for Modernizing the 510(k) Pathway can get you there.
Through this virtual conversation, you’ll gain crucial insights into the FDA’s plans for updates to these important procedures and requirements, along with their effects on the regulatory process for most medical devices. We’ll talk about best practices, common mistakes manufacturers make and the agency’s expectations around 510(k) submissions.
Medical device regulatory affairs expert Mary Vater will share the ways the process is being modernized by the FDA, including advances in technology, safety and the capabilities of this new generation of devices. She will discuss the best ways to navigate the 510(k) process — considering the updated safety and performance criteria, the difficulties of obtaining clearances, the benefits these changes have for the public and what you should anticipate for your future submissions.
- Changes to the 510(k) Process
- Implications for companies who choose predicates cleared over 10 years ago
- Public identification of companies
- Identifying suitable predicate devices
- Moving beyond premarket comparisons
- Understanding and using third-party reviewers
- Common Adverse Events in Product Classification
- Selecting a predicate with a clean history
- Dealing with New Challenges
- Possibility of additional testing to reflect post-market information
- How the FDA is addressing changing biocompatibility requirements
- Issues around reprocessed single-use devices
- Creating and Executing a Test Plan
- Identifying relevant standards and guidance
- Considering most recently cleared devices within the product code
- Best Practices
- Timing for filing a pre-submission
- Questions to ask during a meeting
- Staying current with the latest FDA guidance and enforcement policies
Changes are coming to the FDA’s 510(k) pathway — and if you develop medical devices in the U.S., you can’t avoid the adjustments. Learn how to best navigate these differences and successfully move your product through the process of submission.
Meet Your Presenter
Mary Vater, a biomedical engineer and medical device consultant specializing in regulatory affairs, started her career at a medical device contract manufacturer. She’s taken on several roles in that world, including those in research and development, engineering, and quality assurance. Vater now works with Medical Device Academy, a QA/RA consulting team. In her first year of consulting, she received six 510(k) clearances for her clients, working in the areas of reprocessed medical devices, surgical sutures, software-only medical devices, in vitro diagnostics, and orthopedic implants.
Who Will Benefit
- Medical device companies
- Regulatory affairs specialists
- Medical device consultants
- Biomedical engineers
- Research and development engineers
- Quality professionals
- QSR professionals
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Oct. 21, 2020