The FDA has released both two days of video and all publication presentations from the January 8-9, 2015 public workshop on FDA regulatory of laboratory developed tests.

See: Here.

Agenda and links after the break. 82 presentations were calendared, although a few were withdrawn.

From:

http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm423537.htm

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 FDA’s detailed proposal is outlined in the draft guidance documents entitled “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” and “FDA Notification and Medical Device Reporting for Laboratory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

NIH Campus Visitor Information

The meeting will be webcast.

Webcast

Day 1
Day 2

Presentations

Day 1 [122 pages]
Day 2 [68 pages]

Agenda

January 8, 2015

Time	Subject	Name of Speaker
7:30–8:30	Security screening and Registration
8:30–8:40	Welcome	Cara Tenenbaum
8:40–8:50	Opening Remarks	Jeff Shuren, MD
8:50–9:10	Overview of Proposed Framework	Katherine Serrano
9:10–10:55	Topic 1: Components of a Test and LDT Labeling Considerations
9:15–9:19	Public Comment	1. Howard Coleman (Genelex Corporation)
		2. (withdrawn)
9:20–9:24		3. Makoto Kaneda (MBL International)
9:25–9:29		4. Edward Kim (ASCO)
9:30–9:34		5. Stephen Lyle (KEW Group, Inc)
		6. (withdrawn)
9:35–9:39		7. Aurelia Meloni-Ehrig (CSI Laboratories)
9:40–9:44		8. Alan Mertz (American Clinical Laboratory Association)
9:45–9:49		9. Sam Rua (HTG Molecular Diagnostics, Inc)
9:50–9:54		10. Kelly Slone (National Venture Capital Association)
9:55–9:59		11. Gregory Storch (Pan American Society for Clinical Virology and American Society for Microbiology)
10:00–10:04		12. George Kwass (College of American Pathologists)
10:05–10:50	Panel 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
11:10–12:00	General Topics
11:10–11:14	Public Comment	13. Pranil Chandra (PathGroup)
11:15–11:19		14. Kristina Cusmano-Ozog (CNMC)
11:20–11:24		15. William Finn (American Society for Clinical Pathology)
11:25–11:29		16. Andy Fish (AdvaMedDx)
11:30–11:34		17. Dimitra Georganopoulou (Ohmx Corporation)
11:35–11:39		18. Melinda Griffith (CardioDx, Inc)
11:40–11:44		19. Nandini Gopinadh (Alliance for Natural Health USA)
11:45–11:49		20. Catherine Hammett –Stabler (AACC)
11:50–11:55		81. Michelle Schoonmaker (Cepheid)
11:55–11:59		83. Judith Wilber (CareDx)
12:00–1:15	Lunch Break
1:15–3:00	Topic 2: Clinical Validity/Intended Use
1:20–1:24	Public Comment	21. Dara Aisner (University of Colorado)
1:25–1:29		22. Naomi Aronson (Blue Cross Blue Shield Association)
		23. (withdrawn)
		24. (withdrawn)
		25. (withdrawn)
1:30–1:34		26. Elizabeth Maloney (LymeDisease.org)
1:35–1:39		27. Elissa Passiment (American Society for Clinical Laboratory Science)
1:40–1:44		28. Girish Putcha (Palmetto GBA/MolDx)
		29. (withdrawn)
1:45–1:49		30. Scott Schell (KEW Group)
1:50–1:54		31. (withdrawn)
		32. Jyotsna Shah (IGeneX Inc)
1:55–1:59		33. Mary Sidawy (American Society of Cytopathology)
2:00–2:04		34. (withdrawn)
		35. Emily Volk (College of American Pathologists)
2:05–2:09		36. Ernest Voyard (The Leukemia & Lymphoma Society)
2:10–2:14		37. Qi Wei (Children's Hospital Colorado)
		38. (withdrawn)
2:15–3:00	Panel 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)
3:00–3:20	Break
3:20–4:55	Topic 3: Categories for Continued Enforcement Discretion
3:25–3:29	Public Comment	39. 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)
4:10–4:55	Panel 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)
4:55–5:00	Wrap Up

January 9, 2015

Time	Subject	Name of Speaker
7:00–8:00	Security screening and Registration
8:00–8:10	Welcome	Cara Tenenbaum
8:10–9:10	Topic 4: Notification and Adverse Event Reporting (MDRs)
8:15–8:19	Public Comment	50. Elaine Lyon (ARUP Laboratories)
8:20–8:24	Public Comment	51. Mary Pendergast (Pendergast Consulting)
8:25–9:10	Panel 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)
9:10–10:30	Topic 5: Public Process for Classification and Prioritization
9:15–9:19	Public Comment	52. Edward Ashwood (ARUP Laboratories)
		53. (withdrawn)
9:20–9:24		54. Lawrence Hertzberg (CSI Laboratories)
9:25–9:29		55. Gail Vance (College of American Pathologists)
		56. (withdrawn)
9:30–9:34		57. Paul Kim (Foley Hoag LLP)
9:35–9:39		58. Timothy Lynagh (Lyme Disease Association, Inc.)
		59. (withdrawn)
9:40–9:44		60. Young Wang (MacroGenics)
9:45–10:30	Panel 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)
10:30–10:50	Break
10:50–11:40	General Topics
10:55–10:59	Public Comment	61. Curtis Hanson (Mayo Clinic)
11:00–11:04		62. Amanda Jezek (Infectious Diseases Society of America)
11:05–11:09		63. Donald Karcher (Association of Pathology Chairs)
11:10–11:14		64. Laura Koontz (Ovarian Cancer National Alliance)
11:15–11:19		65. Amy Miller (Personalized Medicine Coalition)
11:20–11:24		66. Federico Monzon (Invitae Corporation)
		67. (withdrawn)
		68. (withdrawn)
11:25–11:29		69. James Prescott (PathGroup)
11:30–11:34		70. Paul Radensky (Coalition for 21st Century Medicine)
11:35–11:39		71. Parmjeet Randhawa (American Society of Transplantation)
11:40–1:00	Lunch Break
1:00–2:30	Topic 6: Quality System Regulation
1:05–1:09	Public Comment	72. 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)
1:45–2:30	Panel 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)
2:30–2:50	Break
2:50–4:50	General Topics
2:50–2:54	Public Comment	82. David Smalley (American Association of Bioanalysts)
3:00–4:50	Public Comment	Anyone 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.
4:50–5:00	Wrap up

Discoveries in Health Policy

Thursday, January 15, 2015

FDA posts Videos, Presentations, From Jan 8-9 LDT Workshop