Medical Devices

Public Workshop - Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy, March 18, 2016 (New Date)

PT/INR Workshop has been postponed and rescheduled for March 18, 2016. Re-registration is not required for current registered participants.

The Food and Drug Administration (FDA) announced the following public workshop entitled “Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy.”

The purpose of this workshop was to discuss and receive input from stakeholders regarding approaches to the analytical and clinical validation of point of care (POC) Prothrombin Time/International Normalized Ratio (PT/INR) in vitro diagnostic devices for improved clinical management of warfarin therapy in addition to describing the FDA’s process for facilitating the development of safe and effective POC and patient self-testing PT/INR devices. The goal of the workshop was to seek and identify potential solutions to address the scientific and regulatory challenges associated with POC PT/INR devices to ensure safety and effectiveness.


Date, Time and Location:

This meeting was held March 18, 2016, beginning at 8:00 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

FDA Campus Information

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Agenda
StartLengthEndSessionTopic/TitleSpeaker
7:00 AM1:008:00 AMRegistrationSecurity screening and pre-registration sign-in 
8:00 AM0:058:05 AMWelcomeWelcomeRachel Goehe, PhD
8:05 AM0:108:15 AMOpeningOpening RemarksAlberto Gutierrez, PhD
8:15 AM0:158:30 AMOverviewWorkshop OverviewLea Carrington, MBA, MS, MT(ASCP)
   AM SessionSession 1 - Clinician and Patient PerspectivesModerator: Rachel Goehe, PhD
8:30 AM0:309:00 AMSession 1Overview of Warfarin TherapyRong Rong, MD, PhD
9:00 AM0:309:30 AMSession 1Point-of-Care INR Testing: A Clinician's PerspectiveMichael Streiff, MD, FACP
9:30 AM0:3010:00 AMSession 1POC INR Results and Monitoring of Warfarin Therapy in an Outpatient Based Anticoagulation ClinicPaul T. Kocis, PharmD, RPh, CACP
10:00 AM0:1010:10 AMSession 1Patient PerspectiveRandy Fenninger, JD
10:10 AM0:1510:25 AMSession 1Patient PerspectiveSue Miller
10:25 AM0:1010:35 AMSession 1Q&A 
10:35 AM0:1510:45 AMBREAKBREAK 
   AM SessionSession 2 - Quality AssessmentModerator: Niquiche Sangster-Guity, PhD
10:45 AM0:2511:10 AMSession 2POC and Lab INRsMarcia Zucker, PhD
11:10 AM0:2511:35 AMSession 2POC PT/INR: Technical Limitations and Laboratory Accreditation IssuesRussell Higgins, MD, FCAP
11:35 AM0:2512:00 PMSession 2CLIA and POC PT/INR DevicesSarah Bennett, MT(ASCP)
12:00 PM0:1012:10 PMSession 2Q&A 
12:10 PM1:001:10 PMLUNCHLUNCH 
   PM SessionSession 3 - CDRH PerspectivesModerator: Cheng Zhang, PhD, MBA
1:10 PM0:351:45 PMSession 3FDA Regulatory Oversight of POC PT/INR DevicesRachel Goehe, PhD & Kennita Riddick, MS
1:45 PM0:202:05 PMSession 3POC PT/INR Devices for Monitoring Warfarin Therapy: An Overview of Statistical ConsiderationsMeijuan Li, PhD
2:05 PM0:452:50 PMSession 3PANEL DISCUSSIONLea Carrington, MBA, MS, MT(ASCP)
Randy Fenninger, JD
Russell Higgins, MD, FCAP
Paul Kocis, PharmD, RPh, CACP
Frank LaDuca, PhD, FAHA
Doug Patterson, MBA
Rong Rong, MD, PhD
Michael Streiff MD, FACP
2:50 PM0:103:00 PMSession 3Q&A 
3:00 PM0:103:10 PMBREAKBREAKBREAK
    Session 4 - Manufacturer PerspectivesModerator: Takeesha Taylor-Bell, H(ASCP)
3:10 PM0:153:25 PMSession 4Manufacturer - AccrivaFrank LaDuca, PhD, FAHA
3:25 PM0:153:40 PMSession 4Manufacturer - AlereRick San George, PhD
3:40 PM0:153:55 PMSession 4Manufacturer - CoaguSenseDoug Patterson, MBA
3:55 PM0:154:10 PMSession 4Manufacturer - RocheThomas Bluethner, MS
4:10 PM0:104:20 PMSession 4Q&A 
4:20 PM0:304:50 PMPublic CommentPublic Comment 
4:50 PM0:105:00 PMWrap UpMeeting Wrap-Up and AdjournLea Carrington, MBA, MS, MT(ASCP)
Registration to Attend the Workshop:

As of March 11th, online registration is now closed. On-site registration will be available the morning of the workshop.

Webcast registration is not needed for this workshop.

Contact Us

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.

For questions regarding workshop content please contact:

Rachel Goehe, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 66 rm. 5533, Silver Spring, MD 20993, 240-402-6565, email: Rachel.Goehe@fda.hhs.gov.

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