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  5. Public Workshop - Self-Collection Devices for Pap Test, January 11, 2018
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Public

Event Title
Public Workshop - Self-Collection Devices for Pap Test, January 11, 2018
January 11, 2018


Date:
January 11, 2018
Time:
04:00 AM - 11:00 AM EST

The Food and Drug Administration (FDA) announced the following public Workshop entitled “Self-Collection Devices for Pap Test.” The purpose of the workshop was to obtain feedback about how the feasibility, benefits and risks impact the current standard of care and least burdensome validation approaches for self-collection cervical sampling devices for the purpose of cervical cancer screening by Pap testing. Comments and suggestions generated through this workshop will guide the development of an appropriate least burdensome regulatory framework for the evaluation of cervical sample self-collection devices to be used for cervical cancer screening of patients.


Date, Time and Location

This meeting was held January 11, 2018, beginning at 9:00 a.m. - 4:00 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

FDA Campus Information (e.g., local airports, directions, local hotels, etc.)

The meeting will be webcast and the link will be available on this page after January 3, 2018. (Registration is not required to view the webcast)

Webcast

Agenda

TimeSubjectSpeakerAffiliation
8:30-9:00Security Screening and Registration
9:00-9:05WelcomeDonald St. PierreActing Director
FDA/CDRH/OIR
9:05-9:20Introduction and Meeting OverviewShyam Kalavar, MPH, CT(ASCP)FDA/CDRH/OIR/DMGP
9:20-9:50Current state of cervical cancer screeningMona Saraiya, MD, MPHCaptain, U.S. Public Health Service
Division of Cancer Prevention and Control/ National Center for Chronic Disease Prevention and Health Promotion/Centers for Disease Control and Prevention
Session 1 - Impact of self-collection on current standard of care
Moderator: Shyam Kalavar, MPH, CT(ASCP)
9:50-10:15Talk 1: Will self-collection of cervical samples improve cervical cancer screening?Paul Staats, MDAssociate Professor of Pathology, University of Maryland
American Society of Cytopathology
10:15-10:40Talk 2: Is self-collection of cervical samples feasible and will it work?Mark Schiffman, MD, MPHSenior Investigator, National Cancer Institute/National Institutes of Health
10:40-11:45Panel DiscussionMona Saraiya, MD, MPHCaptain, U.S. Public Health Service
Division of Cancer Prevention and Control/ National Center for Chronic Disease Prevention and Health Promotion/Centers for Disease Control and Prevention
Dorothy Rosenthal, MDProfessor Emerita of Pathology, Johns Hopkins University
American Society of Cytopathology
Paul Staats, MDAssociate Professor of Pathology, University of Maryland
American Society of Cytopathology
  Mark Schiffman, MD, MPHSenior Investigator, National Cancer Institute/National Institutes of Health
Jacqueline Cunkelman, MD, MPHMedical Officer, Gynecologist, FDA/CDRH/ODE
Tamika FelderPatient Advocate
11:45-1:00    Lunch Break
Session 2 - Performance considerations for self-collection devices
Moderator: Cheng Cui, PhD
1:00-1:25Talk 1: Self-Collection as an Outreach Approach to Increase Cervical Screening in Under-/Un-Screened U.S. Female PopulationsPhilip Castle, PhD, MPHProfessor, Epidemiology and Population Health, Albert Einstein College of Medicine
Global Coalition against Cervical Cancer (GC3)
1:25-1:50Talk 2: Study design issues with validation of Pap tests with samples self-collected at homeMarina Kondratovich, PhDAssociate Director for Clinical Studies, FDA/CDRH/OIR
1:50-2:50Panel DiscussionPhilip Castle, PhD, MPHProfessor, Epidemiology and Population Health, Albert Einstein College of Medicine
Global Coalition against Cervical Cancer (GC3)
Marina Kondratovich, PhDAssociate Director for Clinical Studies, FDA/CDRH/OIR
Christine Booth, MD, FCAPPathologist, Cleveland Clinic Foundation
College of American Pathologists
Richard Conlen, MD, FACOGBoca Raton Obstetrics and Gynecology Associates
Boca Raton, Florida
2:50-3:45Public Comments
3:45-4:00Closing RemarksReena Philip, PhDDirector,
FDA/CDRH/OIR/DMGP

Registration to Attend the Workshop

As of January 4th, online registration is now closed.

Onsite registration will be available the morning of the workshop.

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 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 Susan Monahan, Food and Drug Administration, Center for Devices and Radiological Health, Office of Communication and Education, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5661, Susan.Monahan@fda.hhs.gov.

Contact Us

For questions regarding workshop content please contact:

Shyam Kalavar, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 5660, Silver Spring, MD 20993, 301-796-6807, Shyam.Kalavar@fda.hhs.gov

OR

Cheng Cui, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 5543, Silver Spring, MD 20993, 240-402-5028, Cheng.Cui@fda.hhs.gov