Title |
Presenter Name |
Link |
Overview of Regulatory requirements: Medical Devices |
Bill Sutton: CDHR
Deputy Director of Division of Small Manufacturers, International and Consumer Assistance
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Medical Device User Fee Act (MDUFA) III Implementation |
Barbara Zimmerman, Deputy Director for Program Management of Operations, Office of Device Evaluation |
|
Device Establishment Registration and Listing |
Joe Tartal, Post Market and Consumer Branch Chief, CDRH |
|
The 510(k) Program |
LCDR Kimberly Piermatteo, Regulatory Operations Officer |
|
Part 1: 510(k) Overview |
Heather Rosecrans, Director, 510(k) Staff - Office of Device Evaluation, CDRH, FDA |
|
510(k) Format Guidance, Including Standards Form, and Extensions/Clinical Trial Form and 510(k) |
Marjorie Shulman, Consumer Safety Officer - Premarket Notification (510(k)) Staff - Office of Device Evaluation, |
|
510(k) 3rd Party Review |
Eric Rechen, Policy Analyst - Program Operations Staff - Office of Device Evaluation, CDRH, FD |
|
The De Novo Program |
Elias Mallis, Director of the Division of Industry and Consumer Education |
|
IDE Basics |
Soma Kalb Ph.D, Acting Director, IDE Program |
|
The Pre-Submission Program and Meetings with FDA Staff |
LCDR Kimberly Piermatteo, Regulatory Operations Officer |
|
Standards Overview |
CDR Scott Colburn, Director, Standards Management Staff CDRH |
|
Standards Resources and Premarket Use |
CDR Scott Colburn, Director, Standards Management Staff CDRH |
|
CDRH Standards Recognition Process |
CDR Scott Colburn, Director, Standards Management Staff CDRH |
|
510(k) User Fees |
Marjorie Shulman, Consumer Safety Officer - Premarket Notification (510(k)) Staff - Office of Device Evaluation, CDRH, |
|
|
Elias Mallis, Director of the Division of Industry and Consumer Education |
|
513(g)s, including 513(g) user fees |
Lawrence "Jake" Romanell, Regulatory Affairs and Special Interests Network - Office of the Center Director – CDRH |
|
510(k) Product Codes |
Julie "Brandi" Stuart, Center Product Code Coordinator - Consumer Safety Officer - Office of Device Evaluation, CDRH |
|
BIMO Part 1a - Good Clinical Practice 101: An Introduction |
Lester “Jao” Lacorte MD, Medical Officer |
|
BIMO Part 1b - Introduction to the Bioresearch Monitoring Program |
Janet Cooper, MT, MFS, Consumer Safety Officer |
|
BIMO Part 2a - The Sponsor: Responsibilities in Medical Device Clinical Trials |
Catherine Parker RN, Consumer Safety Officer - CDRH |
|
BIMO Part 2b - The Clinical Investigator: Responsibilities in Medical Device Trials |
Catherine Parker RN, Consumer Safety Officer - CDRH |
|
BIMO Part 2c - Computerized Systems Used in Medical Device Clinical Investigations |
Jonathan Helfgott, MS, Consumer Safety Officer |
|
BIMO Part 3a - Institutional Review Board: Responsibilities in Making the Significant Risk and Non-significant Risk Device Determination |
Janette Collins-Mitchell, MS, RN, Nurse Consultant |
|
BIMO Part 3b - Institutional Review Board: Humanitarian Use Devices (HUDs) |
Fabienne Santel MD, Medical Officer |
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BIMO Part 3c - Institutional Review Board: Compassionate and Emergency Use |
Fabienne Santel MD, Medical Officer |
|
BIMO Part 4a - Preparing for an FDA Sponsor Inspection |
Allen Lou, Consumer Safety Officer |
|
BIMO Part 4b - Preparing for an FDA Clinical Investigator Inspections |
Allen Lou, Consumer Safety Officer |
|
BIMO Part 4c - Preparing for an FDA Institutional Review Board Inspection |
Allen Lou, Consumer Safety Officer |
|
BIMO Part 5a - Strategies for Sponsors to Build Quality into Device Research |
Donna Headlee RN, BSN, CCRP, Consumer Safety Officer |
|
BIMO Part 5b - Strategies For Clinical Investigators to Build Quality into Device Research |
Donna Headlee RN, BSN, CCRP, Consumer Safety Officer |
|
Preparing for a Clinical Investigator Inspection |
N/A |
|
Quality System Regulation 21 CFR 820 Basic Introduction |
Kimberly A. Trautman, Associate Director for International Affairs in the Office of the Center Director, CDRH |
|
Purchasing Controls |
Joe Tartal, Post Market and Consumer Branch Chief, CDRH |
|
Process Validation |
Joe Tartal, Post Market and Consumer Branch Chief, CDRH |
|
Corrective and Preventative Action (CAPA) |
Joe Tartal, Post Market and Consumer Branch Chief, CDRH |
|
Export Certificates for Medical Devices |
CAPT David Racine |
|
Introduction to Medical Device Recalls: Industry Responsibilities |
William (Bill) M. Sutton - Deputy Director - DICE |
|
21 CFR Part 806: Medical Devices - Reports of Corrections and Removals |
Kenneth C. Millen, Lead Compliance Officer, Division of Enforcement A, Office of Compliance, CDRH |
|
Recall Communication: Medical Device Model Press Release |
Ron Brown, Acting Recall Branch Chief for the Division of Risk Management Operations |
|
Recall Communication: Medical Device Model Recall Notification Letter |
Ron Brown, Acting Recall Branch Chief for the Division of Risk Management Operations |
|
Medical Device Recalls: Guidance for Industry |
N/A |
|
Medical Device Reporting and eMDR |
Andrew Xiao, Consumer Safety Officer |
|
MAUDE – Information Available to the Public |
Eugene Reilly, Public Health Analyst, Office of Surveillance and Biometrics |
|
Medical Device Reporting |
Sharon Kapsch, Branch Chief, Reporting Systems Monitoring Branch |
|
MDR for User Facilities |
Sharon Kapsch, Branch Chief, Reporting Systems Monitoring Branch |
|
MDR for Manufacturers and Importers |
Sharon Kapsch, Branch Chief, Reporting Systems Monitoring Branch |
|
IMDRF Medical Device Single Audit Program (MDSAP) Pilot |
Kimberly A. Trautman, Associate Director for International Affairs in the Office of the Center Director, CDRH |
|
Unique Device Identification (UDI) System Regulatory Overview |
Linda Sigg, Associate Director of Informatics CDHR |
|
Global Unique Device Identification Database (GUDID) Account Request: Preparation and Process |
Chris Diamant, UDI Program Analyst, Office of Surveillance and Biometrics, CDHR |
|
The GUDID Device Identifier (DI) Record |
Indria R. Konduri, GUDID Program Manager, CDHR |
|
GUDID HL7 SPL Submission Option |
Linda Sigg, Associate Director of Informatics CDHR |
|
FDA's Home Use Medical Device Initiative |
Mary Weick-Brady, MSN, RN Senior Policy Analyst, CDRH |
|
Promoting Patient Safety with Home Use Devices |
Diana Rivi, MPH Public Health Analyst, CDRH |
|
Home Use Medical Devices: New Risks |
Janette Collins-Mitchell, MT, MS, RN, Nurse Consultant, CDRH |
|
CDRH Regulated Software: An Introduction |
John Murray, CDRH Software Compliance Expert - Division of Enforcement B - Office of Compliance |
|
How To Get Your Electronic Product on the U.S. Market |
CDR Sean Boyd |
|
Phantom Image Scoring (For MQSA Inspectors) |
Thomas Clarida B.S.R.T., Food & Drug Administration
Stephanie Belella, Training Coordinator, MQSA Program, Division of Mammography, FDA |
|
March 2016 Industry Basics Workshop: Unique Device Identification (UDI) Part II, Submitting Information to GUDID |
|
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January 2016 Industry Basics Workshop: Unique Device Identification (UDI) Part I |
|
|
November 2015 Industry Basics Workshop: Purchasing Controls and Process Validation |
|
|
November 2014 Industry Basics Workshop: IDE, 510(k), de novo, CAPA, eMDR
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