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.

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


This workshop will be webcast and registrants will receive the webcast link and final email confirmation a few days prior to the workshop.

Draft Agenda

May 22, 2018

Time Topic Speaker/Moderator
8:30 - 9:00 am Registration 
9:00 Welcome/Introduction Scott Colburn, CAPT USPHS, Director, CDRH Standards

Keynote Opening

Update on FDA's regulatory efforts to promote public health by assuring safety and effectiveness and supporting innovation

Jeff Shuren, MD, JD Director, CDRH
Morning       Break
Plenary Session: What is the ASCA Pilot Program?
  • CDRH Standards and Conformity Assessment Program Overview and Objectives
  • Administrative Requirements of ASCA Pilot Scheme: Working with accreditation bodies and testing laboratories (TLs) in the ASCA Pilot Program  
  • The ASCA Pilot Scheme and ISO/IEC 17025
    General requirements for the competence of testing and calibration laboratories
    • Testing laboratories' roles
    • Understanding a device's Intended Use when testing
    • Understanding Risk Management and Conformity Assessment with standards in the ASCA Pilot
    • How to determine competence of TLs accredited to standards incorporating Risk Management
  • Initial standards under consideration for the ASCA Pilot
Late Morning Question and Answer session on morning session topics  


Mid-afternoon break

Breakout Sessions: Technical Requirements for the ASCA Pilot Breakout Session I: Biocompatibility
  • ISO 10993-4
  • ISO 10993-5
  • ISO 10993-10
  • ISO 10993-11

Criteria for determining which devices are eligible to participate in ASCA PILOT for Biocompatibility

Breakout Session II: Basic Safety and Essential Performance/EMC/Alarms (multiple breakout sessions)

  • ANSI/AAMI ES 60601-1
  • IEC 60601-1-2
  • IEC 60601-1-8
Criteria for determining which devices are eligible to participate in ASCA PILOT for standards related to Basic Safety and Essential Performance
4:45 pm Summary of Day 1 / Expectations for Day 2  

May 23, 2018

Time Topic Speaker/Moderator

9:00 am

Mid-morning break

Technical Breakout Sessions continue from Day 1  



Late Morning Summary of Breakout Sessions Breakout session leads
Afternoon ASCA Pilot Performance Metrics
  • How to measure success for all stakeholders
  • Identify key performance indicators
Mid-Afternoon Break    
  Public Session for Comments/Presentations Registered Public Presenters
  Closing Session/Wrap up ASCA Team
4:15 - 5:00 pm Final Remarks/Next Steps Scott Colburn, CAPT, USPHS

Registration to Attend the Workshop

If you wish to attend this Workshop, you must register by 4:00 pm on May 14, 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,

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Requests to speak must register by May 4, 2018, and any presentations used must be emailed to no later than May 11, 2018.


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:

Page Last Updated: 03/20/2018
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