Medical Devices

Public Workshop - Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers, October 27-28, 2016

The Food and Drug Administration (FDA) is announcing a public Workshop entitled "Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers." The topics to be discussed are the current regulatory environment for these activities, the definitions of the various terms FDA proposed in our prior Federal Register notice on this subject, and whether these activities should appropriately be regulated by FDA or a non-governmental organization. On March 4, 2016, the FDA opened a docket to request comments from individuals and organizations engaged or otherwise interested in the Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices, including radiation-emitting devices subject to the electronic product radiation control provisions of the Federal Food, Drug, and Cosmetic Act. FDA took this action, in part, because various stakeholders have expressed concerns about the quality, safety, and continued effectiveness of medical devices that have been subject to one or more of these activities. This docket asked that Original Equipment Manufacturers (OEMs), health care establishments and third-party entities review proposed terms and definitions and provide edits if applicable. The docket also sought insights into basic concepts with regard to these activities. (View the docket and public comments)

The purpose of the workshop is to convene interested parties to discuss regulatory aspects of third party processes: refurbishing, reconditioning, rebuilding, remarketing, remanufacturing & servicing and address 'Working Questions' that the FDA designed from the comments made to the docket, to promote understanding of challenges and best practices to mitigate risks associated with these activities.


Date, Time and Location

This meeting was held October 27, 2016 and October 28, 2016 from 8:00 a.m. to 5:00 p.m. at the following location:

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

Agenda and Presentations

Day One (Thursday, October 27, 2016)

SessionTimeEvent
 7:15Registration
Morning Session8:00Welcome and Opening Remarks
8:15History of FDA Involvement with Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers
8:30Working Definitions and Overview of Stakeholder Perspectives
9:00Stakeholder Presentations
LUNCH12:00 
Afternoon Session1:00Introduction to Afternoon Agenda
1:05Panel Discussion 1:
Benefits and Risks Associated with Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing Activities
2:35Break
2:45Presentations by Participants
4:50Wrap-up

Day Two (Friday, October 28, 2016)

SessionTimeEvent
 7:30Registration
Morning Session8:15Welcome and Recap of Day 1
8:30Panel Discussion 2:
Characteristics of Good  Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing Entities
10:30Panel Discussion 3:
Challenges Stakeholders Face in Performing High Quality Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing Activities
LUNCH12:00 
Afternoon Session1:00Introduction to Afternoon Agenda
1:05Presentations by Participants
3:10Break
3:20Panel Discussion 4:
Current Best Practices and Future Recommendations
4:50Closing Remarks

Stakeholder Presenters

Panel 1 Panelists

  • David Anbari, Vice President & General Manager, Mobile Instrument Service and Repair Inc.
  • Pat Baird, MBA, MS Patient Safety, Head of Global Software Standards, Philips
  • Hans Beinke, VP, US Quality and Technology, Siemens Healthcare
  • Mark Bruley, CCE, EIT, Vice President, Accident & Forensic Investigation, ECRI Institute
  • Robin Hemphill, MD, MPH, Acting, Assistant Deputy Under Secretary for Health for Quality, Safety & Value, VA National Center for Patient Safety
  • Kanchana Iyer, MS, Senior Regulatory Affairs Specialist, PENTAX of America, Inc.
  • Mark Leahey, JD, MBA, President and CEO, Medical Device Manufacturers Association
  • Wanda Legate, VP Sales and Marketing, Tri Imaging
  • Scot Mackeil, CBET, Senior Anesthesia Biomedical Engineer, Massachusetts General Hospital
  • Rob Moorey, FACHE, Vice President, South Division, TriMedx

Panel 2 Panelists

Panel 3 Panelists

Panel 4 Panelists

Webcast

October 27th

October 28th

Transcripts

Contact Us

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Peggy Roney, Office of Communication and Education, Center for Devices and Radiologic Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 31, Silver Spring, MD 20993, 301-796-5671, Peggy.roney@fda.hhs.gov.

For questions regarding workshop content please contact:

Felicia Brayboy, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 66, Room 5625, Silver Spring MD 20993, 301-796-8086, Felicia.Brayboy@fda.hhs.gov

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