Downloadable Presentations From This Webinar:
Learn about the FDA’s ASCA (Accreditation Scheme for Conformity Assessment) Program and how to save time in your submission process. This is an opportunity for manufacturers to learn more about the overall program, processes and areas that they should be aware of.
Key takeaways:
- What is the ASCA Pilot Program?
- What are the benefits of working with an ASCA-accredited testing laboratory?
- What are ASCA-accredited testing lab responsibilities?
- What is an ASCA Summary Test Report and how is it different from traditional test reports from testing labs?
- How can manufacturers participate in the ASCA Pilot Program?
- How do manufacturers prepare pre-market submissions which use the ASCA Pilot?
- Where do I find additional FDA ASCA resources?
Who should attend this program:
- Regulatory Affairs Professionals and Management
- Quality Professionals and Management
- Design & Development Engineers
- Compliance Engineers
- Medical Device Executives
- In Vitro Diagnostic Executives
- Test Engineers
- Test Laboratories
Leo the “IEC 60601 Guy” Eisner is the Principal Regulatory & Compliance Consultant of Eisner Safety Consultants and has been working in the medical device industry for 27 years.
He is a world renowned IEC 60601 (Medical Electrical Equipment) expert and is involved in the development of the IEC 60601 series where he serves on multiple committees, including the interpretation committee and has helped develop IEC 60601-1, edition 3.2, the latest edition of the standard.
He was on the expert panel for the ASCA Pilot program public workshop, May 22 – 23, 2018, speaking on Essential Performance for the 60601 Series of Standards. He has worked with the FDA to provide feedback on the ASCA Pilot program, the Home Health Care Guidance document, Standards Development, and provided training on Essential Performance for the 60601 series of standards. He is a US co-chair for SC62D committee which is in charge of many of the particular standards, including many for the IEC 60601 series. He recently started working on ISO 15223-1 (4th ed published on July 6, 2021) and has joined other ISO quality system committees. Leo is also a part of the CB Scheme ETF-3 Risk Management Group, and he routinely speaks and writes as an international expert on the IEC 60601 series.
Leo and his team have helped countless clients through the Compliance and Regulatory maze over his career, with over 30 years experience. Leo has audited for several EU Notified Bodies and has been a technical reviewer on Medical Electrical Equipment. He currently does this for NSAI.
Eric Franca received his PhD in Biomedical Engineering from the University of Florida where he investigated novel carbon nano-materials for developing more effective neural electrodes. He began his professional career as a lead reviewer of medical devices at the Food and Drug Administration. He subsequently moved into a policy analyst position managing the content and publication of guidances, orders, and regulations related to medical device review and policies. He currently serves as the Basic Safety and Essential Performance Test Lab Lead in the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program.
Concurrent with his work as a regulator within the FDA, Dr. Franca has participated in standards development, serving in leadership positions in several national bodies and standards development organizations. He was selected as a USNC IEC Young Emerging Professional in 2018 and continues to encourage young people to participate in standards development, including through contributions to the Young Emerging Professional Committee of the USNC.
