Medical Devices

Public Workshop - Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs), January 8-9, 2015

The purpose of this workshop was to discuss FDA’s proposal for a risk-based framework for addressing the regulatory oversight of a subset of in vitro diagnostic devices (IVDs) referred to as laboratory developed tests (LDTs), which are intended for clinical use and designed, manufactured and used within a single laboratory, and provide an additional opportunity for public comment. FDA’s detailed proposal is outlined in the draft guidance documents entitled “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” and “FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs)” issued October 3, 2014. 

The purpose of the workshop was to obtain feedback from all stakeholders on FDA’s proposal so that it can be refined in the best interest of public health.


Date, Time and Location

This meeting will be held January 8-9, 2015, beginning at 8:30am at the following location:

Natcher Center at the NIH Campus
9000 Rockville Pike
Bldg. 45, Auditorium
Bethesda, MD 20814

The meeting will be webcast.

Webcast

Transcripts

Presentations

Agenda

January 8, 2015
TimeSubjectName of Speaker
7:30–8:30 Security screening and Registration
8:30–8:40WelcomeCara Tenenbaum
8:40–8:50Opening RemarksJeff Shuren, MD
8:50–9:10 Overview of Proposed FrameworkKatherine Serrano
9:10–10:55Topic 1: Components of a Test and LDT Labeling Considerations
9:15–9:19Public Comment1. Howard Coleman (Genelex Corporation)
 2. (withdrawn)
9:20–9:243. Makoto Kaneda (MBL International)
9:25–9:294. Edward Kim (ASCO)
9:30–9:345. Stephen Lyle (KEW Group, Inc)
 6. (withdrawn)
9:35–9:397. Aurelia Meloni-Ehrig (CSI Laboratories)
9:40–9:448. Alan Mertz (American Clinical Laboratory Association)
9:45–9:499. Sam Rua (HTG Molecular Diagnostics, Inc)
9:50–9:5410. Kelly Slone (National Venture Capital Association)
9:55–9:5911. Gregory Storch (Pan American Society for Clinical Virology and American Society for Microbiology)
10:00–10:0412. George Kwass (College of American Pathologists)
10:05–10:50Panel Discussion moderated by
Laura Rodriguez (NIH)
Steven Gutman (Illumina/Myraqa)
Catherine Hammett –Stabler (AACC)
Girish Putcha (Palmetto)
Brad Thompson (Combination Products Coalition)
10:50–11:10 Break
11:10–12:00General Topics
11:10–11:14Public Comment13. Pranil Chandra (PathGroup)
11:15–11:1914. Kristina Cusmano-Ozog (CNMC)
11:20–11:2415. William Finn (American Society for Clinical Pathology)
11:25–11:2916. Andy Fish (AdvaMedDx)
11:30–11:3417. Dimitra Georganopoulou (Ohmx Corporation)
11:35–11:3918. Melinda Griffith (CardioDx, Inc)
11:40–11:4419. Nandini Gopinadh (Alliance for Natural Health USA)
11:45–11:4920. Catherine Hammett –Stabler (AACC)
11:50–11:5581. Michelle Schoonmaker (Cepheid)
11:55–11:5983. Judith Wilber (CareDx)
12:00–1:15Lunch Break
1:15–3:00Topic 2: Clinical Validity/Intended Use
1:20–1:24Public Comment21. Dara Aisner (University of Colorado)
1:25–1:2922. Naomi Aronson (Blue Cross Blue Shield Association)
 23. (withdrawn)
 24. (withdrawn)
 25. (withdrawn)
1:30–1:3426. Elizabeth Maloney (LymeDisease.org)
1:35–1:3927. Elissa Passiment (American Society for Clinical Laboratory Science)
1:40–1:4428. Girish Putcha (Palmetto GBA/MolDx)
 29. (withdrawn)
1:45–1:4930. Scott Schell (KEW Group)
1:50–1:5431. (withdrawn)
 32. Jyotsna Shah (IGeneX Inc)
1:55–1:5933. Mary Sidawy (American Society of Cytopathology)
2:00–2:0434. (withdrawn)
 35. Emily Volk (College of American Pathologists)
2:05–2:0936. Ernest Voyard (The Leukemia & Lymphoma Society)
2:10–2:1437. Qi Wei (Children's Hospital Colorado)
 38. (withdrawn)
2:15–3:00Panel Discussion moderated by
Rochelle Long (NIH)
Naomi Aronson (Blue Cross Blue Shield Association)
William Finn (American Society for Clinical Pathology)
Andy Fish (AdvaMedDx)
Cecile Janssens (Emory University)
Elissa Passiment (American Society for Clinical Laboratory Science)
3:00–3:20Break
3:20–4:55Topic 3: Categories for Continued Enforcement Discretion
3:25–3:29Public Comment39. James Boiani (Combination Products Coalition)
3:30–3:34 40. Greg Frank (Infectious Diseases Society of America)
3:35–3:39 41. Jeffrey Gibbs (Hyman, Phelps & McNamara, PC)
3:40–3:44 42. Arthur Hagar (Georgia Public Health Laboratory)
  43. (withdrawn)
3:45–3:49 44. Stuart Hogarth (King's College London)
3:50–3:54 45. Roger Klein (Association for Molecular Pathology)
3:55–3:59 46. Grace Kubin (Texas Department of State Health Services)
  47. (withdrawn)
4:00–4:04 48. Katherine Johansen Taber (American Medical Association)
4:05–4:09 49. Celia Hagan (Association of Public Health Laboratories)
4:10–4:55Panel Discussion moderated by
Derek Scholes (NIH)
Emily Volk (College of American Pathologists)
Curtis Hanson (Mayo Clinic)
Roger Klein (Association for Molecular Pathology)
Laura Koontz (Ovarian Cancer National Alliance) 
TBD (American Association for Cancer Research)
4:55–5:00Wrap Up
January 9, 2015
TimeSubjectName of Speaker
7:00–8:00 Security screening and Registration
8:00–8:10Welcome Cara Tenenbaum
8:10–9:10Topic 4: Notification and Adverse Event Reporting (MDRs)
8:15–8:19Public Comment50. Elaine Lyon (ARUP Laboratories)
8:20–8:2451. Mary Pendergast (Pendergast Consulting)
8:25–9:10Panel Discussion moderated by
Maria Giovanni (NIH)
Clem McDonald (National Library of Medicine)
Christopher Newton-Cheh (American Heart Association)
Jan Nowak (American Medical Association)
Wendy Rubinstein (NIH)
TBD (National Society for Genetic Counselors)
9:10–10:30Topic 5: Public Process for Classification and Prioritization
9:15–9:19Public Comment52. Edward Ashwood (ARUP Laboratories)
 53. (withdrawn)
9:20–9:2454. Lawrence Hertzberg (CSI Laboratories)
9:25–9:2955. Gail Vance (College of American Pathologists)
 56. (withdrawn)
9:30–9:3457. Paul Kim (Foley Hoag LLP)
9:35–9:3958. Timothy Lynagh (Lyme Disease Association, Inc.)
 59. (withdrawn)
9:40–9:4460. Young Wang (MacroGenics)
9:45–10:30Panel Discussion moderated by
Barbara Zehnbauer (CDC)
Andy Fish (AdvaMedDx)
David Flannery (American College of Medical Genetics)
Len Lichtenfeld (American Cancer Society)
Amy Miller (Personalized Medicine Coalition)
Gregory Storch (Infectious Diseases Society of America)
10:30–10:50Break
10:50–11:40General Topics
10:55–10:59Public Comment61. Curtis Hanson (Mayo Clinic)
11:00–11:0462. Amanda Jezek (Infectious Diseases Society of America)
11:05–11:0963. Donald Karcher (Association of Pathology Chairs)
11:10–11:1464. Laura Koontz (Ovarian Cancer National Alliance)
11:15–11:1965. Amy Miller (Personalized Medicine Coalition)
11:20–11:2466. Federico Monzon (Invitae Corporation)
 67. (withdrawn)
 68. (withdrawn)
11:25–11:2969. James Prescott (PathGroup)
11:30–11:3470. Paul Radensky (Coalition for 21st Century Medicine)
11:35–11:3971. Parmjeet Randhawa (American Society of Transplantation)
11:40–1:00Lunch Break
1:00–2:30Topic 6: Quality System Regulation
1:05–1:09Public Comment72. Andrea Ferreira-Gonzalez (Medical College of Virginia)
1:10–1:14 73. Nick Harris (IGeneX Inc)
1:15–1:19 74. Vinod Jyothikumar (George Washington University)
1:20–1:24 75. Shinobu Kitamura (MBL International Corporation)
1:25–1:29 76. Liz Lison (Advocea LLC)
  77. (withdrawn)
1:30–1:34 78. Robin Stombler (Microbiologics)
1:35–1:39 79. Katherine Tynan (Tynan Consulting LLC)
1:40–1:44 80. Sheila Walcoff (Goldbug Strategies LLC)
1:45–2:30Panel Discussion moderated by
Larry Brody (NIH)
Gail Vance (College of American Pathologists)
Andrew Hoofnagle (University of Washington)
Elaine Lyon (ARUP Laboratories)
Scott Patterson (Amgen)
Judith Wilber (CareDx)
Mickey Williams (NIH)
2:30–2:50Break
2:50–4:50General Topics
2:50–2:54Public Comment82. David Smalley (American Association of Bioanalysts)
3:00–4:50Public CommentAnyone who did not register for public comment online may register on-site to speak in this session. The duration of individual slots will be based on the number of on-site requests, up to 4 minutes each.
4:50–5:00Wrap up

Registration to Attend the Workshop

Online registration is closed as of December 12th.

If you have registered for in-person attendance and can no longer attend, please e-mail LDTframework@fda.hhs.gov so that we may open your slot to our waitlist.

If you would like to be put on a waitlist for possible in-person attendance or register for the webcast, please e-mail LDTframework@fda.hhs.gov.

Note that FDA is no longer scheduling public comment slots. All who registered to speak by the deadline have been notified of the date, time, and duration of their slot. Any individuals who did not register to speak in a public comment session may sign up on-site to speak during a general session in the afternoon of January 9, 2015. The duration of their speaking time will depend on the number of interested parties, but will not exceed the time given to advance registrants. Slides cannot be accomodated for on-site speaking registrations.

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 Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5661, FAX: 301-847-8142, susan.monahan@fda.hhs.gov.

For questions regarding workshop content please contact: Allen Webb, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, Food and Drug Administration, Bldg 66, rm 5675, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240-402-4217, LDTframework@fda.hhs.gov

Page Last Updated: 01/23/2015
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