Medical Devices

Public Workshop - Accreditation Scheme for Conformity Assessment (ASCA) of Medical Devices to FDA-Recognized Standards, May 22-23, 2018

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.

Event Name in the App Directory - "Public Workshop - Accreditation Scheme for Conformity Assessment"

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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:
Room A:

Slideshow Presentations

Day 1

Day 2

Agenda

Introduction

May 22, 2018

Time

Topic

Name of Speaker/Moderator

8:00am-9:00am

Registration 

Registration Desk

9:00am

Welcome
Great Room B/C

Scott Colburn Director, CDRH Standards Program

9:05am

Introductory Remarks
Dr. Shuren will introduce the ASCA program and discuss how it supports the Agency’s goals to serve public health, assure medical device safety and effectiveness, support innovation and promote international harmonization.

Dr. Jeff Shuren – Center Director of CDRH

9:20am

 

 

 

 

Plenary Session: What is the ASCA Pilot Program?
Great Room B/C

  • CDRH Standards and Conformity Assessment Program Overview and Objectives
  • Updates to Section 514(c) and 514(d) of the FD&C Act.
  • The importance of speaking the same language – Terminology for the ASCA Workshop.
  • Value proposition of ASCA: How ASCA improves the appropriate use of standards to stakeholders
  • Administrative Requirements of ASCA Pilot Scheme Working with accreditation bodies and testing organizations in the ASCA Pilot Program –
  • The ASCA Pilot Scheme & ISO/IEC 17025
    General requirements for the competence of testing and calibration laboratories
    • Roles that accreditation bodies have in ASCA
    • Roles that testing organizations have in ASCA
  • Main objectives for rest of conference

Scott Colburn, CDRH

10:45am-11:00am
Break

 

 

11:00-11:30am

Plenary Session: ISO/IEC 17025: 2017 and Draft NIST Conformity Assessment Publications
Great Room B/C

Major Changes and Impacts to the Revision of ISO/IEC 17025

Overview of Draft NIST Conformity Assessment Publications:

  • ABC’s of Conformity Assessment
  • Conformity Assessment Considerations for Federal Agencies

 

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
Lunch

 

 

1:00pm-5:00pm

 

Breakout Sessions on the Technical Requirements for the ASCA Pilot:
[15 min Break at 2:30pm]

 

1:00pm-5:00pm

Breakout Session I
Great Room A

Biocompatibility:

Introduction
FDA Moderated ASCA Scheme Considerations

  • Topic 1:  Proposed Biocompatibility Tests & Discussion
  • Topic 2:  Proposed Roles/Responsibilities:  Key Stakeholders & Discussion
  • Topic 3:  Brainstorming Session - ASCA Scheme Discussion Points & Discussion
  • Topic 4:  Proposed ASCA Test Report Summary & Discussion

Biocompatibility Breakout Day 1 Wrap Up

 

Dr. Edward Margerrison, Director Office of Science Engineering Laboratories (OSEL)

Moderators:
Dr. Molly Ghosh, Deputy Director (Acting), Division of Biology, Chemistry and Material Science , OSEL
Jennifer Goode, Biocompatibility Program Advisor, Office of Device Evaluation (ODE)

Dr. Shuliang Li, Senior Standards Advisor, CDRH Standards and Conformity Assessment Program

1:00pm - 2:30pm

Breakout Session II
Great Room B&C

60601 Plenary Session on Basic Safety and Essential Performance:

Opening Remarks

FDA’s Expectations on Assessing Basic Safety and Essential Performance for Medical Devices

  • Engineering vs. Clinical Issues
  • Improving Collaboration Between Manufacturers and Testing Laboratories

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.
Associate Director for Engineering and Quality Management, OSEL

Leonard (Leo) Eisner, P.E.
Principal Consultant, Eisner Safety Consultants

Alex Grob
Chief Biomedical Engineer & Assistant Quality Manager, Medical Equipment Compliance Associates LLC

Dana Leaman, Chief, National Voluntary Laboratory Accreditation Program (NVLAP)

2:30pm-2:45pm
Break

 

 

2:45pm – 4:30pm

Breakout Session II
Great Room B/C + Rooms 1504 & 1408

60601 Basic Safety and Essential Performance/EMC/Alarms (multiple breakout sessions)
Goals of the Breakout Sessions:

  1. Find the Value ASCA Provides to Stakeholders
  2. Gather Issues, Concerns and Suggestions from Stakeholders for Implementation of the Accreditation Scheme
  3. Identify Suitable Candidate Standards and Scope for Pilot Program
  4. Identify Criteria for Determining Competency of ASCA Testing Laboratories for Testing of the Standards in accordance with the ASCA Scheme based upon ISO/IEC 17025
Each Subgroup Will Take a Deep Dive into Each Standard Proposed in the ASCA Pilot Program and Walk Through How Testing Laboratories Establish Their Requirements to ISO/IEC 17025.

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:
Brian Fitzgerald BsC. Senior Technical Advisor, OSEL

Alford Taylor, Jr.
Associate Director for Engineering and Quality Management, OSEL

Brian Beard,
Deputy Director
Division of Biomedical Physics, OSEL

Seth Seidman, Research Biomedical Engineer
Division of Biomedical Physics, OSEL

Shawn Forrest, Biomedical Engineer
Division of Cardiovascular Devices, ODE

Christopher Scully,
Biomedical Engineer
Division of Biomedical Physics, OSEL

4:30pm-5:00pm

Breakout Session II
Great Room B/C

60601 Basic Safety and Essential Performance –
All Subgroups – Summary of Day 1 (if needed)

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
Great Room A

Biocompatibility (Continue from Day 1)

  • Test-Specific Biocompatibility Roundtable Discussion: Challenges, Key Steps, Proficiency
    • Proposed In Vitro Biocompatibility Tests for ASCA Pilot
      • MEM Elution (ISO 10993-5)
      • Hemolysis (ISO 10993-4, ASTM F756)
      • Complement Activation (ISO 10993-4)
    • Proposed In Vivo Biocompatibility Tests for ASCA Pilot
      • Guinea Pig Maximization (GPMT) & Closed Patch Sensitization (ISO 10993-10)
      • Intracutaneous Reactivity & Dermal Irritation (ISO 10993-10)
      • Acute Systemic Toxicity (ISO 10993-11)
      • Material-Mediated Pyrogenicity (ISO 10993-11, USP <151>)
  • Biocompatibility Breakout Day 2 Wrap Up

 

 

Moderators:
Dr. Molly Ghosh, Deputy Director (Acting), Division of Biology, Chemistry and Material Science , OSEL

Jennifer Goode, Biocompatibility Program Advisor, ODE

Dr. Shuliang Li, Senior Standards Advisor, CDRH Standards Program

9:00am-11:00 am

Breakout Session II
Great Room B/C + Rooms 1408, 1504

60601 Basic Safety and Essential Performance, EMC, Alarms
(Continue in multiple breakout sessions or meet as a combined 60601 group based upon work on Day 1)

IEC 60601-1-2: Room 1504

JOIN WEBEX MEETING
https://fda1.webex.com/fda1/j.php?MTID=m7d7339fac6e87f3c9f47365a9196edea
Meeting number (access code): 902 673 739
Meeting password: Asca6060112

JOIN BY PHONE
+1-210-795-0506 US Toll
+1-877-465-7975 US Toll Free
 

IEC 60601-1-8: Room 1408

JOIN WEBEX MEETING
https://fda1.webex.com/fda1/j.php?MTID=me9b85a3c7a9be3316ac4e028c218b21c
Meeting number (access code): 900 503 272
Meeting password: ASCAb6060118

JOIN BY PHONE
+1-210-795-0506 US Toll
+1-877-465-7975 US Toll Free

Moderators:
Brian Fitzgerald BsC. Senior Technical Advisor, OSEL

Alford Taylor, Jr.
Associate Director for Engineering and Quality Management, OSEL

Brian Beard,
Deputy Director
Division of Biomedical Physics, OSEL

Seth Seidman, Research Biomedical Engineer
Division of Biomedical Physics, OSEL

Shawn Forrest, Biomedical Engineer
Division of Cardiovascular Devices, ODE

Christopher Scully,
Biomedical Engineer
Division of Biomedical Physics, OSEL

11:00-11:15am
Break

 

 

11:15am-12:15pm

Plenary Session
Great Room B/C

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
Lunch

 

 

1:00pm-2:30pm

Plenary Session: ASCA Pilot Performance Metrics
Great Room B/C

 

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
Great Room B/C

All Participants

3:30pm-4:30pm

Workshop Summary and Next Steps
Great Room B/C

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.

Page Last Updated: 06/07/2018
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