FDA Video Directory
FDA Video Directory
Topic Area: Medical Devices
| Title | Presenter Name | Link |
|---|---|---|
| Overview of Regulatory requirements: Medical Devices | Bill Sutton: CDHR
Deputy Director of Division of Small Manufacturers, International and Consumer Assistance |
http://fda.yorkcast.com/webcast/Play/040308365ec8405bad39b06de8561bdc1d |
| Medical Device User Fee Act (MDUFA) III Implementation | Barbara Zimmerman, Deputy Director for Program Management of Operations, Office of Device Evaluation | http://fda.yorkcast.com/webcast/Play/072dd831ae74454fb05bbe409458487c1d |
| Device Establishment Registration and Listing | Joe Tartal, Post Market and Consumer Branch Chief, CDRH | http://fda.yorkcast.com/webcast/Play/08c63c1209aa4af28a7e691ddf87a3a81d |
| The 510(k) Program | LCDR Kimberly Piermatteo, Regulatory Operations Officer | http://fda.yorkcast.com/webcast/Play/d91af554691c4260b5eca0b2a28e636b1d |
| Part 1: 510(k) Overview | Heather Rosecrans, Director, 510(k) Staff - Office of Device Evaluation, CDRH, FDA | http://fda.yorkcast.com/webcast/Play/e0ea02ad4f0c4532a98fa9406caa01d0 |
| 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, | http://fda.yorkcast.com/webcast/Play/7a8fa9b887004ff2b2b72d4035e3916c |
| 510(k) 3rd Party Review | Eric Rechen, Policy Analyst - Program Operations Staff - Office of Device Evaluation, CDRH, FD | http://fda.yorkcast.com/webcast/Play/cace6e43f57d47639911944180eb17b3 |
| The De Novo Program | Elias Mallis, Director of the Division of Industry and Consumer Education | http://fda.yorkcast.com/webcast/Play/9058dda0731f4cbdaf8ee37be10a9eb51d |
| IDE Basics | Soma Kalb Ph.D, Acting Director, IDE Program | http://fda.yorkcast.com/webcast/Play/696d857b34334d5389364ed8c2db3ded1d |
| The Pre-Submission Program and Meetings with FDA Staff | LCDR Kimberly Piermatteo, Regulatory Operations Officer | http://fda.yorkcast.com/webcast/Play/854abe570f0a4000a90931767e12d6191d |
| Standards Overview | CDR Scott Colburn, Director, Standards Management Staff CDRH | http://fda.yorkcast.com/webcast/Play/1c662ddc83a14a66ab28ba48b4200d211d |
| Standards Resources and Premarket Use | CDR Scott Colburn, Director, Standards Management Staff CDRH | http://fda.yorkcast.com/webcast/Play/f00e6d6a7a0f43398828ac2a815e946d1d |
| CDRH Standards Recognition Process | CDR Scott Colburn, Director, Standards Management Staff CDRH | http://fda.yorkcast.com/webcast/Play/8866483d519d4e4f9d94d5ee20b8e9ae1d |
| 510(k) User Fees | Marjorie Shulman, Consumer Safety Officer - Premarket Notification (510(k)) Staff - Office of Device Evaluation, CDRH, | http://fda.yorkcast.com/webcast/Play/a7f98ad6e09646fba8b8a2a8c3008849 |
| Elias Mallis, Director of the Division of Industry and Consumer Education | http://fda.yorkcast.com/webcast/Play/bac3f2698df14fa98388409da5cba6831d | |
| 513(g)s, including 513(g) user fees | Lawrence "Jake" Romanell, Regulatory Affairs and Special Interests Network - Office of the Center Director – CDRH | http://fda.yorkcast.com/webcast/Play/c3f0f2dc62444e07aa5ea7dbc954cea4 |
| 510(k) Product Codes | Julie "Brandi" Stuart, Center Product Code Coordinator - Consumer Safety Officer - Office of Device Evaluation, CDRH | http://fda.yorkcast.com/webcast/Play/2360fdf6adf7468aaebd0431ffd76ace |
| BIMO Part 1a - Good Clinical Practice 101: An Introduction | Lester “Jao” Lacorte MD, Medical Officer | http://fda.yorkcast.com/webcast/Play/477af877491747379c36c4ab1c7421b9 |
| BIMO Part 1b - Introduction to the Bioresearch Monitoring Program | Janet Cooper, MT, MFS, Consumer Safety Officer | http://fda.yorkcast.com/webcast/Play/96f1ee7896ee4a70876b601f533b4a9c |
| BIMO Part 2a - The Sponsor: Responsibilities in Medical Device Clinical Trials | Catherine Parker RN, Consumer Safety Officer - CDRH | http://fda.yorkcast.com/webcast/Play/88f92205e9624bbea1d627126af5360f |
| BIMO Part 2b - The Clinical Investigator: Responsibilities in Medical Device Trials | Catherine Parker RN, Consumer Safety Officer - CDRH | http://fda.yorkcast.com/webcast/Play/29b55c1dd3f64d8fa74ca2227df14b39 |
| BIMO Part 2c - Computerized Systems Used in Medical Device Clinical Investigations | Jonathan Helfgott, MS, Consumer Safety Officer | http://fda.yorkcast.com/webcast/Play/be7b1972ea0e414ea48171d433feadf9 |
| 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 | http://fda.yorkcast.com/webcast/Play/389cda9506134988a1ac3cc5a725ce87 |
| BIMO Part 3b - Institutional Review Board: Humanitarian Use Devices (HUDs) | Fabienne Santel MD, Medical Officer | http://fda.yorkcast.com/webcast/Play/679dff2747964a5c90c7274a7313255f |
| BIMO Part 3c - Institutional Review Board: Compassionate and Emergency Use | Fabienne Santel MD, Medical Officer | http://fda.yorkcast.com/webcast/Play/d61c521dee6d4ac28eae61c2700f5237 |
| BIMO Part 4a - Preparing for an FDA Sponsor Inspection | Allen Lou, Consumer Safety Officer | http://fda.yorkcast.com/webcast/Play/d8cc05eef221470c9cd3f9fcdb5ee722 |
| BIMO Part 4b - Preparing for an FDA Clinical Investigator Inspections | Allen Lou, Consumer Safety Officer | http://fda.yorkcast.com/webcast/Play/2c785eeadc754baab704a351a0e5cc19 |
| BIMO Part 4c - Preparing for an FDA Institutional Review Board Inspection | Allen Lou, Consumer Safety Officer | http://fda.yorkcast.com/webcast/Play/a805008fd1ab4a9c9c2e87641e95a86a |
| BIMO Part 5a - Strategies for Sponsors to Build Quality into Device Research | Donna Headlee RN, BSN, CCRP, Consumer Safety Officer | http://fda.yorkcast.com/webcast/Play/225ed5f7301b474196b16c8d9b9a20a5 |
| BIMO Part 5b - Strategies For Clinical Investigators to Build Quality into Device Research | Donna Headlee RN, BSN, CCRP, Consumer Safety Officer | http://fda.yorkcast.com/webcast/Play/b618186c8c9c488f8d951013adf0b635 |
| Preparing for a Clinical Investigator Inspection | N/A | http://fda.yorkcast.com/webcast/Play/e8307dbabea34d30a9fd6a20dead62271d |
| Quality System Regulation 21 CFR 820 Basic Introduction | Kimberly A. Trautman, Associate Director for International Affairs in the Office of the Center Director, CDRH | http://fda.yorkcast.com/webcast/Play/dd2d4823b14a4e4ca6d60eae43c5ac9c |
| Purchasing Controls | Joe Tartal, Post Market and Consumer Branch Chief, CDRH | http://fda.yorkcast.com/webcast/Play/083de1ef7cfb40169e2451492a32ed1e1d |
| Process Validation | Joe Tartal, Post Market and Consumer Branch Chief, CDRH | http://fda.yorkcast.com/webcast/Play/090c4052bc2b4f90ba94245204e745061d |
| Corrective and Preventative Action (CAPA) | Joe Tartal, Post Market and Consumer Branch Chief, CDRH | http://fda.yorkcast.com/webcast/Play/c78cfebf72774163a59f8f6f197435451d |
| Export Certificates for Medical Devices | CAPT David Racine | http://fda.yorkcast.com/webcast/Play/8a0a2d12000a4c3f970d407628db32c3 |
| Introduction to Medical Device Recalls: Industry Responsibilities | William (Bill) M. Sutton - Deputy Director - DICE | http://fda.yorkcast.com/webcast/Play/c830fc5a437d44b384fcefba1a59747c |
| 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 | http://fda.yorkcast.com/webcast/Play/895f808c834f49bfbc230df241fe64501d |
| Recall Communication: Medical Device Model Press Release | Ron Brown, Acting Recall Branch Chief for the Division of Risk Management Operations | http://fda.yorkcast.com/webcast/Play/5cc9c724fd994989a32af7236c0a40711d |
| Recall Communication: Medical Device Model Recall Notification Letter | Ron Brown, Acting Recall Branch Chief for the Division of Risk Management Operations | http://fda.yorkcast.com/webcast/Play/c93236b6dd3d46468b9023bb0f6625381d |
| Medical Device Recalls: Guidance for Industry | N/A | http://fda.yorkcast.com/webcast/Play/1b95461f64be40ecbe3415195cb394911d |
| Medical Device Reporting and eMDR | Andrew Xiao, Consumer Safety Officer | http://fda.yorkcast.com/webcast/Play/409ff7c6e65b4ad1aaf69d73762caf2e1d |
| MAUDE – Information Available to the Public | Eugene Reilly, Public Health Analyst, Office of Surveillance and Biometrics | http://fda.yorkcast.com/webcast/Play/7ddf5dd1e3d3415b8903dbb7a7426b09 |
| Medical Device Reporting | Sharon Kapsch, Branch Chief, Reporting Systems Monitoring Branch | http://fda.yorkcast.com/webcast/Play/36d84dd2f83a4afa94a05698617e4343 |
| MDR for User Facilities | Sharon Kapsch, Branch Chief, Reporting Systems Monitoring Branch | http://fda.yorkcast.com/webcast/Play/205b5a1afd6b439191dd4063fb7cadc0 |
| MDR for Manufacturers and Importers | Sharon Kapsch, Branch Chief, Reporting Systems Monitoring Branch | http://fda.yorkcast.com/webcast/Play/6d700995f4274271a3dd722ed1c27f56 |
| IMDRF Medical Device Single Audit Program (MDSAP) Pilot | Kimberly A. Trautman, Associate Director for International Affairs in the Office of the Center Director, CDRH | http://fda.yorkcast.com/webcast/Play/ae40c79d2479493393241d4a90e586691d |
| Unique Device Identification (UDI) System Regulatory Overview | Linda Sigg, Associate Director of Informatics CDHR | http://fda.yorkcast.com/webcast/Play/455307461f76415ead204eeb03dedad61d |
| Global Unique Device Identification Database (GUDID) Account Request: Preparation and Process | Chris Diamant, UDI Program Analyst, Office of Surveillance and Biometrics, CDHR | http://fda.yorkcast.com/webcast/Play/c3f1d47f147e4865937b6a0f8f1dcdc21d |
| The GUDID Device Identifier (DI) Record | Indria R. Konduri, GUDID Program Manager, CDHR | http://fda.yorkcast.com/webcast/Play/3e1557a3ba4a4de1aac3d07bf8cdf0ee1d |
| GUDID HL7 SPL Submission Option | Linda Sigg, Associate Director of Informatics CDHR | http://fda.yorkcast.com/webcast/Play/2c41f519e6f34e28b2c784795e5ab57a1d |
| FDA's Home Use Medical Device Initiative | Mary Weick-Brady, MSN, RN Senior Policy Analyst, CDRH | http://fda.yorkcast.com/webcast/Play/46b4288ad2a34b71a9d1ff0b9afbd92d1d |
| Promoting Patient Safety with Home Use Devices | Diana Rivi, MPH Public Health Analyst, CDRH | http://fda.yorkcast.com/webcast/Play/8c13f3459ca54e84884a78d67a591b3f1d |
| Home Use Medical Devices: New Risks | Janette Collins-Mitchell, MT, MS, RN, Nurse Consultant, CDRH | http://fda.yorkcast.com/webcast/Play/a8124bbeb8c34aa4904dbc83bdf4e5771d |
| CDRH Regulated Software: An Introduction | John Murray, CDRH Software Compliance Expert - Division of Enforcement B - Office of Compliance | http://fda.yorkcast.com/webcast/Play/4dd89d860ce0449e927a0a8bb92be03f |
| How To Get Your Electronic Product on the U.S. Market | CDR Sean Boyd | http://fda.yorkcast.com/webcast/Play/90191244bb324eb3b0062f9eed35c6ae |
| 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 |
http://fda.yorkcast.com/webcast/Play/4264a7f01789427a847bc0ce62d587fe |
| March 2016 Industry Basics Workshop: Unique Device Identification (UDI) Part II, Submitting Information to GUDID |
|
http://fda.yorkcast.com/webcast/Play/a21960fcc6d44a3380eba129a069cfd81d |
| January 2016 Industry Basics Workshop: Unique Device Identification (UDI) Part I |
|
http://fda.yorkcast.com/webcast/Play/06c7017ec9bd4ef3973cc7872339633b1d |
| November 2015 Industry Basics Workshop: Purchasing Controls and Process Validation |
|
http://fda.yorkcast.com/webcast/Play/85b72f2be2a941648962fc46ccb81aa41d |
|
November 2014 Industry Basics Workshop: IDE, 510(k), de novo, CAPA, eMDR |
|
http://fda.yorkcast.com/webcast/play/c369da3174e945db99747267beeb2a551d |