Medical Devices

Public Workshop - Voluntary Medical Device Manufacturing and Product Quality Program - October 10, 2017

The Food and Drug Administration (FDA) announced a public workshop entitled "Voluntary Medical Device Manufacturing and Product Quality Program."

The purpose of the workshop was to announce the proposed framework and preliminary outline of a voluntary pilot program that recognizes an independent assessment of manufacturing and product quality. The workshop was intended to discuss the framework of the voluntary pilot program, information on the independent assessment, details of participation, rules of engagement, monitoring and performance expectations, as well as potential modifications to FDA's oversight actions in response to demonstrated manufacturing quality performance. FDA is soliciting public feedback to aid in the development of science-based approaches to regulatory decision making for assessing manufacturing quality, extent of manufacturing related submissions, and how to better allocate resources to lower the regulatory burden on manufacturers and FDA.

Date, Time and Location

This meeting will be held October 10, 2017, beginning at 8:00 a.m. - 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

Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to Public Meetings at the FDA White Oak Campus.

Webcast Archive


7:30 - 8:00 AMRegistration 
8:00 - 8:10 AMWelcome and Meeting GoalsJeffrey Shuren
8:10 - 8:55 AMCase for Quality Background and MDIC CollaborationStephanie Christopher
8:55 - 9:40 AMCMMI Institute, Tools, and PlaybookGeorge Zack
Two Harbors Consulting, LLC
Kimberly Kaplan
CMMI Institute
9:40 - 10:00 AMQuality Program Pilot FrameworkRobin Newman
10:05 - 10:30 AMParticipation Criteria and Rules of EngagementCapt. Sean Boyd
10:30 - 10:45 AMBreak
10:50 - 11:25 AMFDA Modifications to Decrease Regulatory BurdenCisco Vicenty
11:25 - 12:00 PMValue Proposition from Stakeholders
Monetizing FDA Incentives
Nathan Tenzer
Edwards Lifesciences
Luann Pendy
12:00 - 1:00 PMLunch 
1:00 - 1:30 PMValue Proposition from Stakeholders
A Paradigm Shift in Driving Improvements
Frank Meledandri
Zoll Life Vest
Cynthia Grossman
Faster Cures
1:30 - 2:15 PMPanel Discussion 1:
Health Outcomes to patients, value to industry, benefits to healthcare
Hudson Garrett
Joe Friedrich
Cynthia Grossman
Al Crouse
Adrian Furey
Robin Newman
2:15 - 3:00 PMPanel Discussion 2:
Identifying Risks and Mitigation Strategies
George Zack
Pat Baird
Cisco Vicenty
Al Crouse
Cindy Winfrey
Emily Miner
3:00 - 3:10 PMBreak 
3:10 - 5:00 PMOpen public session for Presentations by Participants
Driving a Culture of Operational Quality Excellence
Voluntary Quality Program Considerations
The Maturity Model Journey
5:00 - 5:05 PMClosing Remarks 

Workshop Moderators: George Serafin (Session I), Erin Keith (Session II)

Registration to Attend the Workshop

As of September 28, online registration is closed. On-site registration will be available the morning of the meeting.

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 wish to speak during the open comment sessions at the meeting you must indicate this at the time of registration. FDA requests that comments focus on the areas defined in the Federal Register Notice. FDA will do its best to accommodate requests to speak.

If you wish to make an oral presentation during any of the open comment sessions at the meeting you must indicate this at the time of registration. FDA requests that presentations focus on the areas defined in the Federal Register Notice. You should also identify which discussion topic you wish to address in your presentation and you must submit a brief statement that describes your experience and/or expertise relevant to your proposed presentation. In order to keep each open session focused on the discussion topic at hand, each oral presentation should address only one discussion topic. FDA will do its best to accommodate requests to speak .

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 Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5671,

Contact Us

For questions regarding workshop content please contact:

Francisco Vicenty,
Food and Drug Administration,
Center for Devices and Radiological Health,
10903 New Hampshire Ave., Bldg. 66, Room 3426, Silver Spring, MD 20993,
Tele: 301-796-5577,

Page Last Updated: 09/12/2018
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