FDA 510(k) Course Overview
The FDA is modernising 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.
John E. Lincoln, Principal of J. E. Lincoln and Associates LLC 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. He’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.
Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar
- 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 favourable 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 post market 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 guidance’s and looking into the most recently cleared devices within your product code
- What the best time is to file your pre submission 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
- All Regulatory Affairs Specialists
- Any Medical Device Consultants
- Biomedical Engineers
- Research and Development Engineers
- Any Regulatory, Quality and Compliance Professionals
John E. Lincoln
Medical Devices / Regulatory Consultant; also pharma and dietary supplements
Saint George, Utah
John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years experience in U.S. FDA-regulated industries, 18 of which as a full time independent FDA-regulated industry consultant. Mr. Lincoln has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS / CGMP audits and problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).
Our Participants Testimonial
The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )
Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.
Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody that has implemented these regulations in a working lab. Virtual Seminar on ( Training on Life cycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines )
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I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )
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The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )
Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals
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About World Compliance Seminars (WCS)
World Compliance Seminars (WCS) is one stop solution for all your pharmaceutical, biotechnology and medical device certification program needs. The pharmaceutical and medical device training requirements are set forth by the FDA (Food and Drug Administration) and other major regulatory bodies like NIH, EMA, as well as numerous European based national regulatory bodies.
These requirements are important to the training of pharmaceutical reps who are responsible for the education, professional development, and on-the-job training. The training is broken down into different sections to cover a wide variety of topics, including pharmaceutical formulation, pharmaceutical transfer processes , GLP, GMP, Clinical Compliance, Process Validation, Global Regulatory Affairs, Document Management,GMP (Good manufacturing practice) QSR and CMC and many more.
The pharmaceutical and medical device requirements that the FDA has set forth are designed to protect the public's health and safety. Pharmaceutical reps must adhere to all of the regulations and education courses provided by the FDA in order to be considered one of the best in their field. They also must complete ongoing educational opportunities and maintenance programs in order to maintain relevance and career enhancement.