Accreditation of U.S. FDA ASCA testing labs
Accreditation of U.S. FDA ASCA testing labs
Accreditation of testing laboratories under the U.S. FDA ASCA program requirements
Assuring Confidence in your Service or Product
Medical devices and products have a direct impact on public health and safety. Therefore, it's crucial to be able to prove the highest level of safety and good quality through accreditation. This webinar provides important information for German testing laboratories and European medical device manufacturers outside the US about the U.S. Food and Drug Administration (U.S. FDA) Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program.This voluntary program recognizes accredited testing laboratories and is designed to help make medical device and in vitro diagnostic product (IVD) premarket reviews more consistent and efficient. The FDA also intends for the program to reduce the regulatory burden on device manufacturers by increasing product reviewers’ trust in medical device testing.This free webinar is to learn more about the laboratory accreditation requirements, the new FDA ASCA program, and IAS as an FDA approved accreditation body.
Outline
- Introduction by the U.S. Commercial Service in Germany
- U.S. FDA Background & Expectations for ASCA
- IAS Overview about Laboratory Accreditation Process
- Underwriters Laboratories Accreditation Experience
- Frequently Asked Questions
Your Instructor
Brittany Banta
Brittany Banta joined the U.S. Embassy in Berlin as a Commercial Attaché in July 2019. Previously, she served as a Commercial Officer and Digital Attaché at the U.S. Embassy in Tokyo, Japan where she helped American tech companies navigate digital economy and cybersecurity policy challenges, increase their exports, and expand their presence in Japan. From 2014-2016 Brittany served at the U.S. Export Assistance Center in New Orleans, where she worked with the Louisiana business community on exporting.
Prior to joining the U.S. Department of Commerce, Brittany managed the consumer and industrial goods trade portfolio at UK Trade & Investment at the British Consulate-General in New York. She graduated from the University of Miami and the Florida State University College of Law and was admitted as an attorney to the New York bar in 2009.
Eric Franca
Eric Franca received his PhD in Biomedical Engineering from the University of Florida where he investigated novel carbon nanomaterials 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.
Dimitrios Katsieris
Dimitrios Katsieris is the Senior Global Manager for Testing Laboratories and Food Accreditation Programs, with IAS. Dimitrios has an MSc Food Chemist. He is also IAS Program Manager for FDA/FSMA Program and Medical Laboratories Program. He is a Lead Assessor and Trainer for a number of accreditation programs. He is an active individual in ISO and ISO/CASCO committees for the development of International Standards and has great experience in medical devices conformity assessment schemes/regulations in many regions around the world (e.g. Europe, Latin America - Brazil).
Pamela Gwynn
Pamela Gwynn serves as the Principal Engineer with UL LLC (Underwriters Laboratories Inc.) Life and Health Sciences (HS) Division with global responsibilities for Medical Electrical Equipment (60601 series of standards), Personal Health and Hygiene Appliances and Nurse Call Equipment.Pamela has over 30 years of experience in the product safety business related to medical electrical devices and personal health and hygiene appliances.
Pamela is responsible for technically developing and maintaining programs within UL’s L&HS business related to medical electrical devices and other healthcare appliances. She is also a member of many working groups in both the international and US committees related to TC 62 Medical Equipment in Medical Practices and its associated subcommittees.
Additionally, Pamela serves as the Program Manager for the LHS team for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot program.