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Thursday 22 March 2018

SECTION 1— (FDA) Regulatory Update
8:30 am–8:45 am Welcome Rob Jensen, AAMI President and CEO  
8:45 am–9:15 am 21st Century Cures Act, FDA Reauthorization Act of 2017 [FDARA] Joni Foy, Acting Associate Director of Policy, CDRH/FDA Dr. Foy provides an update and overview of Agency initiatives and policies following the passage of the 21st Century Cures Act and FDA Reauthorization Act of 2017.
9:15 am–9:45am Preparing for the Future: Transforming CDRH to Reflect the Total Product Life Cycle Erin Keith, Director, Div. of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices, and TPLC Project Lead Director Keith provides an overview of the restructuring of the CDRH to incorporate a Total Product Lifecyle (TPLC) model and align with the Agency’s and Center’s strategic priorities to ensure CDRH is prepared to adapt to future changes in the medical device industry.
9:45 am–10:10 am

Accreditation Scheme for Conformity Assessment [ASCA]

Capt. Scott Colburn, Director, Standards Program, CDRH/FDA Capt. Colburn provides an overview of the FDA ASCA pilot program for recognizing accredited testing laboratories that evaluate medical devices per certain FDA-recognized standards.  The goal of this pilot program is to streamline the standards conformity assessment of medical devices during the premarket review process where standards are used.
10:10 am–10:30 am

CDRH Standards Program Update

Sharon Lappalainen, Deputy Director, Standards Program, CDRH/FDA Learn about updates being made to the CDRH recognition program as well as how standards are being utilized in support of key efforts within the 21st Century Cures Act and FDARA.
10:30 am–10:45 am BREAK
10:45 am–11:30 am

FDA Digital Health Initiatives

Session 1—Digital Health Program Action Plan and the FDA PreCert Program (Follow-up to FDA workshop in January 2018)
Bakul Patel, Associate Director for Digital Health, CDRH/FDA
John Murray, CDRH/FDA
Industry panelists TBA
11:30 am–12:15 pm

FDA Digital Health Initiatives

Session 2—21st Century Cures Act and Digital Health (MDSS, EHRA CDSS, Multifunctionality), FDA Guidance related to digital health (Interoperability, Software 510ks, Cybersecurity)
Bakul Patel, Associate Director for Digital Health, CDRH/FDA
John Murray, CDRH/FDA
Industry panelists TBA
12:15 pm–1:00 pm NETWORKING LUNCH
SECTION 2— International Update (Global, including U.S. and Europe) Update 
1:00 pm–2:00 pm IMDRF Update—Update on IMDRF initiative and related regulatory actions—Standards, Good Regulatory Practice, UDIs, Essential Principles Gail Rodriguez, CDRH/FDA
Erin Keith, CDRH/FDA
Terrie Reed, CDRH/FDA
Jeff Eggleston, Medtronic
A panel of industry and regulatory experts review the work of the IMDRF and related regulatory actions related to standards, Good Regulatory Practice, UDIs, and Essential Principles.
2:00 pm–2:45 pm

Medical Device Quality Systems—Today and Tomorrow

Session 1—The Present: What is happening today with respect to quality systems
Eamonn Hoxey, AAMI Chair-Elect
Paul Sim, BSI
Marc-Henri Winter, Staff Fellow, CDRH/FDA

Session 1 focuses on current activities and short-term expectations with respect to QS, including:

  • Implementation of ISO 13485:2016 (deadlines for implementation)
  • Update on MDSAP (Single Accreditation Program)
  • Update on Case for Quality
  • ISO Quality Management Handbook
  • EU recognition and mapping to the MDD & MDR (including planned CEN Technical Report)
2:45 pm–3:00 pm BREAK
3:00 pm–3:45 pm

Medical Device Quality Systems—Today and Tomorrow

Session 2—The Future: What additional changes to QMS regulations, standards and implementation may be coming in 2019 and beyond
Eamonn Hoxey, AAMI Chair-Elect
Paul Sim, BSI
Keisha Thomas, Deputy Director, Premarket and Labeling Compliance, CDRH/FDA

Session 2 focuses on longer-term changes:

  • Update from FDA on QSM regulations
  • Plans for future alignment of ISO 13485 with ISO 9001:2016 and ISO High Level Management Structure
  • QMS for ancillary sectors
3:45 pm–4:30 pm

Risk Management—Revision of ISO 14971 and critical issues for the future

Jos van Vroonhoven,  Philips
Erin Keith, CDRH/FDA
Patti Krantz-Zuppen, Medtronic
Mr. van Vroonhoven reviews the changes being considered in the balloted revision of ISO 14971 and, with the panel, will discuss the future direction of risk management for medical technology.
4:30 pm–5:15 pm Postmarket Surveillance—Update on European, FDA and initiatives in Postmarket Surveillance and development of the ISO work on postmarket surveillance Tina Krenc, KTA Compliance Consulting
Don Powers
, Powers Consulting
Marc-Henri Winter
, Staff Fellow, CDRH/FDA
Industry participants TBA
The panel will discuss the FDA and ISO efforts to address postmarket surveillance.

Friday 23 March 2018

SECTION 3—European Focus (EU MDR review)
8:00 am−8:30 am

EU Regulations—What’s Changing

Bill Enos, BSI
Todd Moorman, BSI
This introductory session covers what is changing and why around the EU regulations. This high-level briefing will cover the impact of the new regulations for manufacturers and industry.
8:30 am–9:30 am MDR—Classification, Conformity Assessment, GSPRs, Technical Documentation/PMS documentation Bill Enos, BSI
Ibim Tariah, BSI
Get an overview of the MDR Annexes including Classification Rules (Annex VIII), Conformity Assessment (Annex IX-XI), General Safety and Performance (Annex I), Technical File Documentation (Annex II) and Post-Market Surveillance Technical Documentation (Annex III).
9:30 am–10:15 am IVDs— In Vitro Diagnostics Ian Purdy, Haemonetics Review the requirements for IVDs arising from the MDRs and the IVDRs.
10:15 am–10:30 am BREAK
10:30 am–11:30 am

MDR—Risk and Clinical Requirements

Bill Enos, BSI
Ibim Tariah, BSI
Dig deep into the Risk and Clinical Requirements under the MDR. Topics include, risk-benefit analysis, clinical investigations, whena clinical investigation is required, expectations above and beyond MDEDEV 2.7.1 Rev 4, and changes to conformity assessment procedures.

11:30 am–12:15 pm

SECTION 4—Focus on the Future—Emerging Issues and Technologies
12:15 pm–1:00 pm Developing National and International Cybersecurity Standards Anita Finnegan, Nova Leah
Ken Hoyme, BSCI
Suzanne Schwartz, FDA
Survey and discuss ongoing efforts addressing medical device and health IT network cybersecurity.
1:00 pm–1:45 pm Additive Manufacturing (3D Printing)— Overview of current regulatory guidance and planned development of standards Matthew DiPrima, FDA
James Coburn, FDA
Lauralyn McDaniel, SME (invited)
Review FDA guidance on additive manufacturing, the ANSI-AMSC Additive Manufacturing Roadmap (medical focus), and the plans of ISO/TC 261, Additive manufacturing, to develop standards for the medical device sector.
 1:45 pm–2:25 pm Artificial Intelligence and Medical Algorithms Pat Baird, Philips
Sahiner Berkman, FDA (invited)
Review ongoing efforts to explore educational, regulatory and standards needs relating to artificial intelligence and algorithms utilized in clinical care technology.
2:25 pm–2:30 pm Closing Remarks

Eamonn V. Hoxey, AAMI Chair-Elect



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