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  4. Public Workshop - Accreditation Scheme for Conformity Assessment and Use of Chemical Analysis to Support Biocompatibility of Medical Devices - 11/06/2024
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Workshop | Mixed

Event Title
Public Workshop - Accreditation Scheme for Conformity Assessment and Use of Chemical Analysis to Support Biocompatibility of Medical Devices
November 6, 2024

Date:
November 6, 2024
Time:
8:00 AM - 5:00 PM ET

Summary

The Food and Drug Administration (FDA) announced a public workshop entitled “Accreditation Scheme for Conformity Assessment and Use of Chemical Analysis to Support Biocompatibility of Medical Devices.” The purpose of this public workshop was for the FDA to discuss with stakeholders the expansion of the Accreditation Scheme for Conformity Assessment (ASCA) program to include chemical analysis to support biocompatibility of medical devices.

Background

The workshop was a public forum for engaging with testing laboratories, device manufacturers, trade associations, accreditation bodies, and the general public. It focused on stakeholders’ experiences associated with analytical chemistry testing used for medical devices’ toxicological risk assessment. The public workshop intended to facilitate the sharing of information about analytical chemistry testing and the discussion of pathways for expanding the ASCA program to include standardized approaches to chemical analysis (e.g., ISO10993-18 Biological Evaluation of Medical Devices. Part 18: Chemical characterization of medical device materials within a risk management process).

For more information on the ASCA program, please refer to the ASCA website.

Date, Time, and Location

This meeting was held November 6, 2024, from 8:00 am to 5:00 p.m. (ET) at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993

Webcast

Workshop recording: https://fda.zoomgov.com/rec/share/42o4wNY5W5RcISIro6ZWXxhFdh-PPJMdSEY3FZsVPd9TRVl2lAJAPdN6x7Wd7uFi.SO6w8ft1v-71LbCV 

The recording is split into 2 sessions: one before lunch and one after. When you click on the link it will bring you to the zoom recording, at the bottom of the recording is a small forward arrow. This arrow will take you to the second half of the day. Same for if you would like to watch the first half again but the arrow will be in reverse.

Agenda

Time Subject Name of Speaker
8:00 am - 8:30 am Sign-in / Registration  
8:30 am - 8:45 am Welcome and Introduction Terry Woods, Ph.D.
8:45 am - 9:00 am Opening Remarks / Background Ed Margerrison, Ph.D.
9:00 am - 10:00 am

Session 1: Current methods and challenges

  
  Interlaboratory study for extraction testing of medical devices​ David Saylor, Ph.D.
  Proficiency testing proposal Shuliang Li, Ph.D.
  Panel discussion FDA panelists
10:00 am - 10:15 am Break  
10:15 am - 12:00 pm

Session 2: Presentations from FDA and invited stakeholders
Topic:

  
  Example coverage map: chemical analysis of medical devices 

Jennifer Goode, B.S.
  Framework for developing a coverage map for chemical analysis of medical devices. 

Industry and testing laboratories speakers
  Panel discussion FDA panelists and industry and testing laboratories speakers
12:00 pm - 12:45 pm Lunch  
12:45 pm - 3:00 pm

Session 3: FDA-led panel discussion
Topics:
What should be considered when developing a general approach to chemical analysis of medical devices?

  • Test article preparation
  • Test article extraction
  • Extract processing
  • Reporting threshold

FDA-led panel
3:00 pm - 3:15 pm Break  
3:15 pm - 4:30 pm

Session 4: FDA-led panel discussions
Topics:
What should be considered when developing a general approach to chemical analysis of medical devices?

  • Extract analysis
  • Identification and quantification
  • Personnel competency evaluation
  • ASCA Summary Test Report

FDA-led panel
4:30 pm - 4:45 pm Wrap up Ed Margerrison, Ph.D.

Registration

Registration is closed.

Comments

Please submit your comments to Docket FDA-2024-N-3336 by December 6, 2024.

Please refer to the Instructions for submitting comments to the docket to ensure that your feedback is received.

Contact

For questions regarding the public workshop content please contact:

Shuliang Li
Center for Devices and Radiological Health
Office of Readiness and Response (ORR)
Office of Strategic Partnerships and Technology Innovation (OST)
10903 New Hampshire Ave.
Silver Spring MD 20993
ASCA@FDA.HHS.GOV

Event Materials

Title File Type/Size
Instructions for Submitting Comments for 11/6/2024 ASCA Workshop pdf (137.69 KB)
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