Register today for SDRAN's November 2024 In-Person & Virtual Event!
What Regulatory Affairs Professionals Need to Know About the New CDRH/CBER Draft Guidance on Chemical Analysis for Biocompatibility Assessment of Medical Devices: A discussion of potential implications for the medical device industry
🔗 Registration link: https://lnkd.in/dH5NskTT
💡Program Topic: The FDA Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) recently released a long-awaited draft guideline titled, Chemical Analysis for Biocompatibility Assessment of Medical Devices (https://lnkd.in/ehR7zuGZ). As stated in the document, the goal of this draft guidance is to: “describe recommended methodological approaches for chemical analysis for biocompatibility assessment of medical devices.” The draft guidance further states, “The recommendations provided in this guidance are intended to improve consistency and reliability of analytical chemistry studies and are based on FDA’s experience evaluating such studies submitted as part of premarket submissions to demonstrate device biocompatibility.” At the upcoming SDRAN meeting, Ron Brown from the Risk Science Consortium, LLC and Sherry Parker from SParker Toxicology Consulting, LLC will provide a high level overview of the approaches described in the draft guidance and will explore the implications of the proposed changes for the medical device industry.
📅 Date: Thursday, November 14, 2024
⏲ Time: 5:30 PM- 8:00 PM Pacific Time
📍Location: Zoom &
Neurocrine Biosciences
12790 El Camino Real
San Diego, California 92130
(NO registration at the door is allowed.)
💲Registration Price: SDRAN members ($20 In-Person, $10 Virtual), for Non-Members ($30 In-Person, $20 Virtual)
🗣 Program Speakers:
Ron Brown, Risk Science Consortium, LLC
https://lnkd.in/gNfkYsPg
Sherry Parker, SParker Toxicology Consulting, LLC
https://lnkd.in/drdFQQz8
Join or renew your #SDRAN membership now at https://lnkd.in/gqRxKR7K!
#regulatoryaffairs
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