Public
Event Title
Public Workshop - Accreditation Scheme for Conformity Assessment (ASCA) of Medical Devices to FDA-Recognized Standards, May 22-23, 2018
May 22 - 23, 2018
- Date:
- May 22 - 23, 2018
- Time:
-
5:00 PM - 1:00 PM ET
The Food and Drug Administration (FDA), is announcing the following public workshop entitled "Accreditation Scheme for Conformity Assessment (ASCA) of Medical Devices to FDA-Recognized Standards." The purpose is to present a draft design of the ASCA pilot program and to discuss and obtain input and recommendations from stakeholders on the draft accreditation scheme, including its goals and scope of, and a suitable framework and procedures and requirements.
- Date, Time and Location
- Federal Register Notice
- Webcast Archive
- Slideshow Presentations
- Agenda
- Transcripts
- ASCA Definitions and References [PDF - 506 KB]
- Registration
- Contact Us
Download the Workshop App:
Desktop version: https://crowd.cc/fda-asca2018
Mobile device version: https://crowd.cc/s/1zzsM
Twitter: #ASCAFDA
Date, Time and Location
This meeting will be held May 22-23, 2018, beginning at 9:00 am - 5:00 pm at the following location:
FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993
Webcast Archive
Room B/C:
-
Day 1
-
Day 2
Room A:
Slideshow Presentations
Day 1
Day 2
Transcripts
Agenda
Introduction
May 22, 2018
Time |
Topic |
Name of Speaker/Moderator |
---|---|---|
8:00am-9:00am |
Registration |
Registration Desk |
9:00am |
Welcome |
Scott Colburn Director, CDRH Standards Program |
9:05am |
Introductory Remarks |
Dr. Jeff Shuren – Center Director of CDRH |
9:20am
|
Plenary Session: What is the ASCA Pilot Program?
|
Scott Colburn, CDRH |
10:45am-11:00am |
|
|
11:00-11:30am |
Plenary Session: ISO/IEC 17025: 2017 and Draft NIST Conformity Assessment Publications Major Changes and Impacts to the Revision of ISO/IEC 17025 Overview of Draft NIST Conformity Assessment Publications:
|
Warren Merkel - Chief of Standards Services in the Standards Coordination Office, NIST Amy Phelps – Conformity Assessment, Standards Coordination Office, NIST
|
11:30am-12:15pm |
Public Session |
Registered Speakers |
12: 15pm-1:00pm |
|
|
1:00pm-5:00pm
|
Breakout Sessions on the Technical Requirements for the ASCA Pilot: |
|
1:00pm-5:00pm |
Breakout Session I Biocompatibility: Introduction
Biocompatibility Breakout Day 1 Wrap Up |
Dr. Edward Margerrison, Director Office of Science Engineering Laboratories (OSEL) Moderators: Dr. Shuliang Li, Senior Standards Advisor, CDRH Standards and Conformity Assessment Program |
1:00pm - 2:30pm |
Breakout Session II 60601 Plenary Session on Basic Safety and Essential Performance: Opening Remarks FDA’s Expectations on Assessing Basic Safety and Essential Performance for Medical Devices
What Are Some of the Major Challenges Facing Manufacturers and Testing Laboratories? What Are Some of the Major Challenges to Improve Manufacturers and Testing Laboratories Collaborations to meet FDA Regulatory Requirements in Testing to Standards in 60601 Family? How Do Accreditation Bodies, Testing Laboratories and Manufacturers Manage Requirements for Testing/Expertise Under ISO/IEC 17025? Accreditation Bodies Perspective on ASCA Pilot and Working with Regulatory Bodies.
|
Dr. Zane Arp, Director Division of Biomedical Physics, OSEL Brian Fitzgerald BsC. Senior Technical Advisor, OSEL Alford Taylor, Jr. Leonard (Leo) Eisner, P.E. Alex Grob Dana Leaman, Chief, National Voluntary Laboratory Accreditation Program (NVLAP) |
2:30pm-2:45pm |
|
|
2:45pm – 4:30pm |
Breakout Session II 60601 Basic Safety and Essential Performance/EMC/Alarms (multiple breakout sessions)
To include perspectives from all key stakeholders, we’d like to invite experts from manufacturers, accreditation bodies, and testing organizations to bring their experience and questions in working with ISO/IEC 17025 and the 60601 family of standards to identify gaps and challenges where the ASCA scheme can help address. |
Moderators: Alford Taylor, Jr. Brian Beard, Seth Seidman, Research Biomedical Engineer Shawn Forrest, Biomedical Engineer Christopher Scully, |
4:30pm-5:00pm |
Breakout Session II 60601 Basic Safety and Essential Performance – |
Breakout Session Moderators |
5:00pm |
Adjourn for Day 1 |
|
May 23, 2018
Time |
Topic |
Name of Speaker/Moderator |
---|---|---|
8:00am-9:00am |
Registration |
Registration Desk |
9:00am-11:00am |
Breakout Session I Biocompatibility (Continue from Day 1)
|
Moderators: Jennifer Goode, Biocompatibility Program Advisor, ODE Dr. Shuliang Li, Senior Standards Advisor, CDRH Standards Program |
9:00am-11:00 am |
Breakout Session II 60601 Basic Safety and Essential Performance, EMC, Alarms IEC 60601-1-2: Room 1504 JOIN WEBEX MEETING IEC 60601-1-8: Room 1408 JOIN WEBEX MEETING JOIN BY PHONE |
Moderators: Alford Taylor, Jr. Brian Beard, Seth Seidman, Research Biomedical Engineer Shawn Forrest, Biomedical Engineer Christopher Scully, |
11:00-11:15am |
|
|
11:15am-12:15pm |
Plenary Session Summary of Breakouts on the ASCA Scheme to the Standards Outlined in the Pilot. Question and Answer Session. |
Breakout Session Moderators |
12:15-1:00pm |
|
|
1:00pm-2:30pm |
Plenary Session: ASCA Pilot Performance Metrics
What does success look like for all stakeholders? What are the key performance indicators? What areas can be improved in testing, standards development and in regulatory science platforms where standards are used from the ASCA Pilot?
|
Angela Krueger, PhD, Deputy Director, ODE Elisabeth George, Philips Healthcare – Chair MITA Standards WG Jamie Wolszon, JD, AdvaMed Jennifer Padberg, Senior VP of Standards, AAMI |
2:30-2:45pm Break |
|
|
2:45-3:30pm |
Open Public Session |
All Participants |
3:30pm-4:30pm |
Workshop Summary and Next Steps |
ASCA Team |
4:30pm |
Adjourn Workshop |
Registration to Attend the Workshop
Online registration is now closed. Onsite Registration will be available beginning at 8:00 am on May 22, 2018.
There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.
If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communication and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5661, susan.monahan@fda.hhs.gov.
Contact Us
CAPT Scott Colburn, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring MD 20993, email: standards@cdrh.fda.gov.