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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