OIVD Public Meetings and Presentations
This section links to upcoming public meetings and presentations
by OIVD staff.
Upcoming Meetings
To Be Announced
Archived Meetings and Presentations
OIVD Conducts the Annual 510(k) Workshop on April 22-23, 2008
The Office of In Vitro Diagnostic Devices (OIVD) at The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA), and the Association of Medical Diagnostics Manufacturers (AMDM) will co-sponsor the OIVD’s Annual 510(k) Workshop on April 22-23, 2008 at the Marriott Bethesda North Hotel and Conference Center, 5701 Marinelli Road, N. Bethesda, Maryland. The objective of the Annual 510(k) Workshop is to foster communication between the professional, manufacturing and regulatory community. This interactive workshop provides an opportunity to hear about 510(k) submissions from the FDA people who actually review the submissions. Helpful tips and guidance from experienced industry regulatory affairs personnel will also be provided.
In an effort to encourage the industry to use the electronic 510(k) submission program (Turbo 510(k) program) OIVD has organized a half a day hands on training for the participants to complete and package for submission an electronic 510(k). To participate in this hands-on interactive training session participants must have a laptop; OIVD will provide CDs for loading the software onto the laptops.
For more information see the Agenda.
AMDM/FDA - OIVD 510(k) Workshop
OIVD Conducts the Annual 510(k) Workshop on April 17-18, 2007
Source: The Office of In Vitro Diagnostic Devices at The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA), and the Association of Medical Diagnostics Manufacturers (AMDM), February 15, 2007
The Office of In Vitro Diagnostic Devices at The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA), and the Association of Medical Diagnostics Manufacturers (AMDM) will co-sponsor the OIVD’s Annual 510(k) Workshop on April 17-18, 2007 at the Marriott Bethesda North Hotel and Conference Center, 5701 Marinelli Road, N. Bethesda, Maryland. The objective of the Annual 510(k) Workshop is to foster communication between the professional, manufacturing and regulatory community. This interactive workshop provides an opportunity to hear about 510(k) submissions from the FDA people who actually review the submissions. Helpful tips and guidance from experienced industry regulatory affairs personnel will also be provided.
For more information see the Agenda.
EDRN and FDA Co-sponsored Educational Workshop
The Office of In Vitro Diagnostic Device evaluation and safety (OIVD) at the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA), and the Early Detection Research Network (EDRN) of the National Cancer Institute (NCI) at the National Institutes of Health (NIH) co-sponsored the EDRN/OIVD educational workshop at the Natcher Conference Center on the NIH campus in Bethesda, MD on February 15, 2007.
The purpose of this workshop was to open dialogue between OIVD staff that review premarket applications for all the in vitro diagnostic devices and the EDRN scientists currently performing clinical validation studies on cancer biomarkers. Issues related to FDA’s premarket and postmarket requirements for the in vitro diagnostic devices were presented by OIVD personnel. Representatives from EDRN provided details on supporting data of their validation studies and the resources developed within EDRN to facilitate such research for compliance with FDA’s requirements.
See the Agenda for the content of the workshop and the presentations by the speakers at this workshop.
Meeting on In Vitro Diagnostic Multivariate Index Assays
For more information, see the news announcement.
OIVD’s Clinical Chemistry and Clinical Toxicology Devices Panel Meeting
For more information, see the news announcement.
OIVD’s Immunology Devices Panel Meeting (November 16, 2006)
For more information, see the news announcement.
IVD Roundtable 510(k) Workshop on April 18-19, 2006
The Office of In Vitro Diagnostic Devices at The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA), and the Association of Medical Diagnostics Manufacturers (AMDM) will co-sponsor the IVD Roundtable 510(k) Workshop on April 18-19, 2006 at the Double Tree Hotel, 1750 Rockville Pike, Rockville, MD. The objective of the IVD Roundtable 510(k) Workshop is to foster communication between the professional, manufacturing and regulatory community. This interactive workshop provides an opportunity to hear about 510(k) submissions from the FDA people who actually review the submissions. Helpful tips and guidance from experienced industry regulatory affairs personnel will also be provided.
For more information see the Agenda.
NCI/FDA Workshop: Research Strategies, Study Designs and
Statistical Approaches to Biomarkers Validation for Cancer Diagnosis
and Detection on July 28-29, 2004
The National Cancer Institute in cooperation with the Food and
Drug Administration (FDA), invite you to participate in the workshop
to be held in Gaithersburg, MD on July 28-29, 2004. The workshop
is designed to review the basic considerations underpinning the
study design, statistical methodologies and validation approaches
to rapidly advancing field of cancer biomarker and consider approaches
to their validation for clinical utility, including randomized
controlled-trial (RCT)- based and non-RCT based validation designs.
Invited speakers and discussion panelists will address the various
aspects of biomarker validation: high throughput, high-dimensional
data analysis deriving from genomic and proteomic technologies
and statistical considerations on study designs for data collection
including preprocessing of data.
The workshop participants will also discuss the FDA guidelines
for technology and biomarker evaluation, analytical performance
characteristics, biomarker validation regulatory requirements
for commercialization, unconventional approaches to data validation
and analysis, approaches to piggybacking validation study to ongoing
prevention and treatment trials, case-control study designs based
on completed trials, and suitability of samples for proteomics
and genomic assays for validation study;
A major goal of this workshop is to stimulate discussions related
to statistical considerations of cancer biomarker validation for
cancer detection and diagnosis and to develop a position paper
on state-of-the-art in biomarker validation study.
IVD Roundtable 510(k) Workshop on April 20-21, 2004
The Office of In Vitro Diagnostic Devices at
The Center for Devices and Radiological Health (CDRH) of the Food
and Drug Administration (FDA), and the Association of Medical
Diagnostics Manufacturers (AMDM) will co-sponsor the IVD Roundtable
510(k) Workshop on April 20-21, 2004 at the Double Tree Hotel,
1750 Rockville Pike, Rockville, MD. The objective of the IVD Roundtable
510(k) Workshop is to foster communication between the professional,
manufacturing and regulatory community. This interactive workshop
provides an opportunity to hear about 510(k) submissions from
the FDA people who actually review the submissions. Helpful tips
and guidance from experienced industry regulatory affairs personnel
will also be provided.
|Agenda|
FDA/Industry IVD Roundtable meeting held in Rockville,
MD, October 24th, 2003,
Dr. Steve Gutman in his presentation at the, focused on risk
analysis and risk management plans for IVD products and on recalls.
[Text] [Powerpoint]
Regulatory Affairs Professionals Society (RAPS) 2003 Annual
Conference held on October 19-22, 2003
Don St. Pierre, Deputy Director, of OIVD provided an overview
of the OIVD and an update on experience and progress since its
formation during the Regulatory Affairs Professionals Society
(RAPS) 2003 Annual Conference held on October 19-22, 2003 at the
Baltimore Waterfront Marriott Hotel in Baltimore, MD. Hot topics
such as current initiatives including Total Product Life Cycle
(TPLC), IVD Compliance, and new approaches to pre-market review
were discussed.
[Text] [Powerpoint]
[Text] [Powerpoint]
2003 Educational Conference IVD Focus XII, sponsored by
the Association of Medical Diagnostics Manufacturers in San Diego
on September 18-19, 2003.
Dr. Sally Hojvat, the Director of Microbiology Division, OIVD,
presented an Overview of the newly formed OIVD in the 2003 Educational
Conference IVD Focus XII, sponsored by the Association of Medical
Diagnostics Manufacturers in San Diego on September 18-19, 2003.
CDC-sponsored conference surrounding Quality Control material
for Genetic Testing in Atlanta, Georgia on September 15-16, 2003.
Dr. Tim O’Leary, Director, and Dr. Maria Chan, Senior Reviewer,
of the Immunology and Hematology Division, in OIVD presented in
a CDC-sponsored conference surrounding Quality Control material
for Genetic Testing in Atlanta, Georgia on September 15-16, 2003.
The conference has three main goals:
· To review the current and future needs for QC materials
for genetic tests;
· To describe the efforts to produce materials suitable
for positive QC for genetic tests
· To develop a sustainable, practical means to provide
QC materials to genetic testing laboratories at a reasonable cost.
Clinical Education & Events, Duke Clinical Research
Institute, on September 14-16, 2003, held in Rockville, MD.
Dr. Steve Gutman, Director of OIVDpresented in the Device Assessment
Think Tank meeting sponsored by the Clinical Education & Events,
Duke Clinical Research Institute, on September 14-16, 2003, held
in Rockville, MD.
Dr. Steve Gutman, Director of OIVD represented the FDA in a CDC-sponsored
meeting addressing the Laboratory component of the preparedness
plan. He will be providing guidance regarding issues surrounding
testing done with “home-brew” assays. The meeting
is scheduled for September 18th, 2003, in Atlanta Georgia.
Dr. Steve Gutman, Director of OIVD represented the FDA in the
CLIAC meeting held on September 17-18, 2003 in Atlanta Georgia.
13th Annual Medical Device Submission Workshop sponsored
by the Advanced Medical Technology Association (AdvaMed) held in
Washington D.C. on June 4-5, 2003
Don St. Pierre, the OIVD Deputy Director, presented the audience
with updates in OIVD at the 13th Annual Device Submission Workshop
sponsored by the Advanced Medical Technology Association (AdvaMed)
held in Washington D.C. on June 4-5, 2003
[Text] [Powerpoint]
Clinical Ligan Assay Society Meeting sponsored by the Clinical
Ligan Assay Society on May 10, 2003 in Hunt Valley, MD
Steve Gutman, M.D., Director of the OIVD, Discussed the “FDA’s
Role in the Regulation of In Vitro Diagnostics and the The Creation
of the OIVD during a meeting sponsored by the Clinical Ligan Assay
Society on May 10, 2003 in Hunt Valley, MD
[Text] [Powerpoint]
[Text] [Powerpoint]
Annual Meeting of the Pan America Society for Clinical
Virology on April 27-30, 2003
Kathy Wright, Senior Reviewer, Discussed “How Decision
Making Drives Viral Testing” during the Clinical Virology
Symposium in conjunction with the annual meeting of the Pan America
Society for Clinical Virology held in April 27-30, 2003, in Clearwater,
FL
[Text] [Powerpoint]
[Abstract]
Association of Medical Dianostics Manufacturers (AMDM)
Annual Meeting on April 24-25, 2003
Dr. Elizabeth Mansfield Discussed the content of the newly released
Guidance Document entitled "Multiple Tests for Heritable
DNA Markers, Mutations and Expression Patterns" at the Banbury
Conference at the Banbury Center, Cold Spring Harbor, NY held
on April 13-15, 2003 as well as at the Association of Medical
Diagnostics Manufacturers (AMDM) Annual Meeting on April 24-25,
2003
[Text] [Powerpoint]
IVD Roundtable 510(k) Workshop on April 22-23,
2003
The Center for Devices and Radiological Health (CDRH) of the
Food and Drug Administration (FDA), and the Association of Medical
Diagnostics Manufacturers (AMDM) co-sponsored the IVD Roundtable
510(k) Workshop on April 22-23, 2003 at FDA’s Parklawn Building,
in Rockville, MD. The objective of the IVD Roundtable 510(k) Workshop
was to foster communication between the professional, manufacturing
and regulatory community. This interactive workshop provided an
opportunity to hear about 510(k) submissions from the FDA people
who actually review the submissions. Helpful tips and guidance
from experienced industry regulatory affairs personnel was also
provided.
Abbreviated 510(k)s by Vernonica Calvin
[Text]
[Powerpoint]
Consensus Standards by Ginette Y. Michaud
[Text]
[Powerpoint]
How to Work with FDA: Industry Perspective by Mark A. Del Vecchio;
Director, Regulatory and Clinical Affairs, Digene Corporation
[Text]
[Powerpoint]
CBER 510(k) Issues by Sheryl A. Kochman
[Text] [Powerpoint]
Premarket Notification (510(k)) by Marjorie Shulman
[Text] [Powerpoint]
The Pre-IDE Process by Sousan S. Altaie
[Text] [Powerpoint]
Replacement Reagent Policy Update (Data for Commercialization
of Original Equipment Manufacturer, Secondary and Generic Reagents
for Automated Analyzers issued 6/10/96) by Jim Callaghan
[Text] [Powerpoint]
Bioresearch Monitoring & In Vitro Diagnostic Devices by Jean
Toth-Allen
[Text] [Powerpoint]
Update 2003: FDA & CLIA by Clara Sliva
[Text] [Powerpoint]
Parting Shots: IVD Roundtable 510(k) Workshop by Steven I. Gutman,
MD
[Text] [Powerpoint]
|
