CDRH Learn

Welcome to CDRH Learn! CDRH Learn is a multi-media educational resource for medical device and radiation-emitting product laws, regulations, guidances, and policies, across the entire product life cycle. These educational resources provide industry with information that is comprehensive, interactive, and easily accessible in a variety of formats, including modules, audio recordings, and slide presentations.

These educational resources constitute an informal communication that represents the information at the time of the posting, and does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.

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Presentation	Type	Date Posted	Topic	Slides	Transcript
An Introduction to FDA's Regulation of Medical Devices	Module	4/23/2019	Medical Device Regulation	Slides	Transcript
Is My Product a Medical Device?	Module	9/30/2019	Device Determination, 513(g) (Request for Classification)	Slides	Transcript
An Introduction to the Medical Device User Fees: MDUFA V	Module	7/19/2023	MDUFA (Medical Device User Fee Amendments)	Slides	Transcript
Small Business Determination Program: Introduction	Module	8/27/2026	SBD (Small Business Determination), MDUFA (Medical Device User Fee Amendments)	Slides	Transcript
Small Business Determination Program: Form 3602N – Section I	Module	8/27/2026	SBD (Small Business Determination), MDUFA (Medical Device User Fee Amendments)	Slides	Transcript
Small Business Determination Program: Form 3602N – Section II	Module	8/27/2026	SBD (Small Business Determination), MDUFA (Medical Device User Fee Amendments)	Slides	Transcript
Small Business Determination Program: Form 3602N – Section III	Module	8/27/2026	SBD (Small Business Determination), MDUFA (Medical Device User Fee Amendments)	Slides	Transcript
Small Business Determination Program: Form 3602N – Section IV	Module	8/27/2026	SBD (Small Business Determination), MDUFA (Medical Device User Fee Amendments)	Slides	Transcript
Small Business Determination Program: Common Submission Errors	Module	8/27/2026	SBD (Small Business Determination), MDUFA (Medical Device User Fee Amendments)	Slides	Transcript
Device Establishment Registration and Listing: An Introduction - Part 1	Module	10/16/2023	Registration and Listing	Slides	Transcript
Device Establishment Registration and Listing: An Introduction - Part 2	Module	10/16/2023	Registration and Listing	Slides	Transcript
Paying the Annual Registration User Fee via the DFUF Website	Module	12/6/2013	Registration and Listing	Slides
FURLS Device Registration and Listing Module for Annual Registration	Other	9/28/2017	Registration and Listing
FURLS Device Registration and Listing Module for Initial Registration	Other	2016	Registration and Listing
The 510(k) Program	Module	11/4/2014	510(k) (Premarket Notification)	Slides	Transcript
CDRH's New Draft Guidances to Continue to Modernize the 510(k) Program	Webinar	10/25/2023	510(k) (Premarket Notification)	Slides	Transcript
Special 510(k) Program: Final Guidance	Webinar	10/31/2019	510(k) (Premarket Notification)	Slides	Transcript
Safety and Performance Based Pathway Performance Criteria for Certain Device Types Final Guidances	Webinar	9/24/2020	510(k) (Premarket Notification)	Slides	Transcript
Safety and Performance Based Pathway Performance Criteria	Webinar	11/7/2019	510(k) (Premarket Notification)	Slides	Transcript
Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics	Webinar	11/1/2018	510(k) (Premarket Notification)	Slides	Transcript
Case Study: Material Substitutions in Devices Subject to Premarket Notification [510(k)] Using Polytetrafluoroethylene (PTFE)	Webinar	12/19/2025	510(k) (Premarket Notification)	Slides	Transcript
Final Guidances on "Deciding When to Submit a 510(k) for a Change to an Existing Device" and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device"	Webinar	11/30/2017	510(k) (Premarket Notification)	Slides	Transcript
De Novo Final Rule: Overview and Guidance Updates	Webinar	12/14/2021	De Novo	Slides	Transcript
De Novo Program	Module	12/8/2014	De Novo	Slides	Transcript
IDE Basics	Module	12/8/2014	IDE (Investigational Device Exemption), Clinical Studies	Slides	Transcript
Final Guidance on Adaptive Designs for Medical Device Clinical Studies	Webinar	9/22/2016	IDE (Investigational Device Exemption), Clinical Studies	Slides	Transcript
Breakthrough Devices Program, Updated Final Guidance [2023]	Webinar	11/20/2023	IDE (Investigational Device Exemption), Clinical Studies, Breakthrough Devices Program	Slides	Transcript
IDEs for Early Feasibility Medical Device Clinical Studies, including First in Human (FIH) Studies	Webinar	10/23/2013	IDE (Investigational Device Exemption), Clinical Studies	Slides	Transcript
FDA Guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices	Webinar	12/4/2013	IDE (Investigational Device Exemption), Clinical Studies	Slides	Transcript
Evaluation of Sex-Specific Data in Medical Device Clinical Studies	Webinar	8/25/2014	IDE (Investigational Device Exemption), Clinical Studies	Slides	Transcript
FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations	Webinar	9/4/2014	IDE (Investigational Device Exemption), Clinical Studies	Slides	Transcript
Clinical Studies/IDE	Webinar	2/23/2017	IDE (Investigational Device Exemption), Clinical Studies	Slides	Transcript
Post-Approval Study Requirements and Postmarket Surveillance under Section 522 of the Federal Food, Drug, and Cosmetic Act, Final Guidances	Webinar	12/8/2022	IDE (Investigational Device Exemption), Clinical Studies	Slides	Transcript
FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions	Webinar	1/16/2018	IDE (Investigational Device Exemption), Clinical Studies	Slides	Transcript
Introduction to the Premarket Approval Application (PMA) Program	Module	11/1/2014	PMA (Premarket Approval Application)	Slides	Transcript
Premarket Approval Application (PMA) Program: Postapproval Requirements	Module		PMA (Premarket Approval Application)	Slides	Transcript
Module 1: Office of Orphan Products Development	Module	6/16/2017	HUD (Humanitarian Use Device), HDE (Humanitarian Device Exemption)	Slides	Transcript
Module 2: Humanitarian Use Device (HUD): Program Overview	Module	6/16/2017	HUD (Humanitarian Use Device), HDE (Humanitarian Device Exemption)	Slides	Transcript
Module 3: Humanitarian Device Exemption (HDE): Program Overview and Pre-approval Activities	Module	6/16/2017	HUD (Humanitarian Use Device), HDE (Humanitarian Device Exemption)	Slides	Transcript
Module 4: Humanitarian Device Exemption (HDE): Post-approval Activities	Module	6/16/2017	HUD (Humanitarian Use Device), HDE (Humanitarian Device Exemption)	Slides	Transcript
Humanitarian Device Exemption Program	Webinar	10/21/2019	HUD (Humanitarian Use Device), HDE (Humanitarian Device Exemption)	Slides	Transcript
Q-Submission Program for Medical Device Submissions	Webinar	6/11/2019	Q-Submission, Pre-Submission	Slides	Transcript
Requests for Feedback: The Pre-Submission Program and Meetings with FDA Staff	Module	9/15/2015	Q-Submission, Pre-Submission	Slides	Transcript
Module 1: Standards Overview	Module	9/22/2017	Standards	Slides	Transcript
Module 2: Standards Resources and Premarket Use	Module	9/22/2017	Standards	Slides	Transcript
Module 3: CDRH Standards Recognition Process	Module	9/22/2017	Standards	Slides	Transcript
Module 4: How to Use Consensus Standards in Premarket Submissions	Module	4/21/2021	Standards	Slides	Transcript
Appropriate Use of Voluntary Consensus Standards	Webinar	10/25/2018	Standards	Slides	Transcript
Recognition and Withdrawal of Voluntary Consensus Standards - Final Guidance	Webinar	10/15/2020	Standards	Slides	Transcript
CDRH Portal Overview and Feature Walkthrough	Module	9/29/2023	CDRH Portal	Slides	Transcript
Combination Product Updates for “Acceptance and Filing Reviews for Premarket Approval Applications” and “Refuse to Accept Policy for 510(k)s”	Webinar	3/20/2018	Combination Product, 510(k) (Premarket Notification), PMA (Premarket Approval Application)	Slides	Transcript
Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions - Final Guidance	Webinar	10/6/2019	Benefit-Risk, PMA (Premarket Approval Application), De Novo, HDE (Humanitarian Device Exemption)	Slides	Transcript
Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approvals and De Novos	Module	4/6/2012	Benefit-Risk, PMA (Premarket Approval Application), De Novo	Slides	Transcript
Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle, Final Guidance	Module	5/15/2026	Patient Preference	Slides	Transcript
The Least Burdensome Provisions: Concept and Principles Final Guidance	Webinar	3/13/2019	Least Burdensome Provisions	Slides	Transcript
Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices	Webinar	8/8/2016	Clinical Studies, Pediatric	Slides	Transcript
Multiple Function Device Products: Policy and Considerations	Webinar	9/12/2020	Multiple Function, Software	Slides	Transcript
Patient Preference Information	Webinar	9/26/2016	Patient Preference	Slides	Transcript
Predetermined Change Control Plans for Medical Devices, Draft Guidance	Webinar	8/29/2024	PCCP (Predetermined Change Control Plans), Digital Health	Slides	Transcript
Safer Technologies Program: Draft Guidance	Webinar	2/1/2021	Safer Technologies	Slides
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, Final Guidance	Town Hall	2/25/2026	RWE (Real-World Evidence)	Slides	Transcript
How is My Medical Device Classified?	Module	9/30/2019	Classification, 513(g) (Request for Classification)	Slides	Transcript
Case Study: How is My Medical Device Classified?	Module	9/30/2019	Classification, 513(g) (Request for Classification)	Slides	Transcript
513(g) Requests for Information	Module	12/4/2019	Classification, 513(g) (Request for Classification)	Slides	Transcript
Medical Device Accessories - Describing Accessories and Classification Pathway for New Accessory Types: Final Guidance	Webinar	2/1/2017	Classification, 513(g) (Request for Classification), Medical Device Accessory	Slides	Transcript
BIMO Part 1- Introduction to the Bioresearch Monitoring Program	Module	11/17/2021	BIMO (Bioresearch Monitoring)	Slides
BIMO Part 3a - Institutional Review Board: Responsibilities in Making Significant Risk and Nonsignificant Risk Determination	Module	6/4/2009	BIMO (Bioresearch Monitoring)	Slides
BIMO Part 3b - Institutional Review Board: Humanitarian Use Devices (HUDs)	Module	6/4/2009	BIMO (Bioresearch Monitoring)	Slides
BIMO Part 4c - Preparing for an FDA Institutional Review Board Inspection	Module	6/5/2009	BIMO (Bioresearch Monitoring)	Slides
BIMO Part 5a - Strategies for Sponsors to Build Quality into Device Research	Module	7/20/2009	BIMO (Bioresearch Monitoring)	Slides
BIMO Part 5b - Strategies for Clinical Investigators to Build Quality into Device Research	Module	7/20/2009	BIMO (Bioresearch Monitoring)	Slides
Overview of Quality Management System Regulation	Module	8/30/2024	QMSR (Quality Management System Regulation)	Slides	Transcript
Navigating the Quality Management System Regulation	Module	8/30/2024	QMSR (Quality Management System Regulation)	Slides	Transcript
Quality Management System Regulation (QMSR): Key Takeaways	Webinar	12/16/2025	QMSR (Quality Management System Regulation)	Slides	Transcript
Quality Management System Regulation (QMSR): Risk Management, Risk-Based Approach, and Risk-Based Decisions	Module	9/30/2025	QMSR (Quality Management System Regulation)	Slides	Transcript
Quality Management System Regulation (QMSR): Design and Development	Module	9/30/2025	QMSR (Quality Management System Regulation)	Slides	Transcript
Quality Management System Regulation (QMSR): Risk and Design and Development	Town Hall	1/30/2026	QMSR (Quality Management System Regulation)	Slides	Transcript
Quality Management System Regulation (QMSR): Medical Device Risk-Based Inspections	Town Hall	4/14/2026	QMSR (Quality Management System Regulation)	Slides	Transcript
Exporting Medical Devices	Module	3/26/2019	Export	Slides	Transcript
Importing Medical Devices Into the United States	Module	1/13/2020	Import	Slides	Transcript
Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act, Final Guidance	Module	7/25/2025	Discontinuance, Interruption, Manufacturing	Slides	Transcript
Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency	Webinar	5/11/2020	Discontinuance, Interruption, Manufacturing	Slides	Transcript
Final Guidance: Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions	Webinar	2/9/2017	Benefit-Risk, Compliance, Enforcement	Slides	Transcript
Remanufacturing of Medical Devices, Final Guidance	Webinar	9/9/2024	Remanufacturing	Slides	Transcript
Computer Software Assurance for Production and Quality System Software, Draft Guidance	Webinar	10/26/2022	Software	Slides	Transcript
Voluntary Improvement Program	Webinar	10/7/2024	Voluntary Improvement Program	Slides	Transcript
Introduction to Medical Device Recalls	Module	4/7/2010	Recall, Correction, Removal	Slides	Transcript
Distinguishing Medical Device Recalls from Medical Device Enhancements	Webinar	11/14/2014	Recall, Correction, Removal	Slides	Transcript
Recall Module 21 CFR Part 806: Medical Devices; Reports of Corrections and Removals	Module	5/20/2011	Recall, Correction, Removal	Slides
Electronic Submission of 806 Reports of Corrections and Removals	Other	6/23/2017	Recall, Correction, Removal	Slides
Overview of Medical Device Reporting	Module	8/22/2019	MDR (Medical Device Reporting)	Slides	Transcript
Medical Device Reporting for Mandatory Reporters	Module	8/22/2019	MDR (Medical Device Reporting)	Slides	Transcript
Electronic Medical Device Reporting (eMDR)	Module	11/4/2014	MDR (Medical Device Reporting)	Slides	Transcript
Medical Device Reporting for Manufacturers, Final Guidance	Webinar	10/22/2021	MDR (Medical Device Reporting)	Slides	Transcript
eMDR eSubmitter and WebTrader Tutorial	Module	11/2/2021	MDR (Medical Device Reporting)		Transcript
Introduction to the MDSAP Program	Module	3/24/2021	Inspections, MDSAP (Medical Device Single Audit Program)	Slides	Transcript
Overview of the MDSAP Audit Process	Module	3/25/2021	Inspections, MDSAP (Medical Device Single Audit Program)	Slides	Transcript
Antimicrobial Susceptibility Test System Devices - Updating Breakpoints in Device Labeling	Webinar	12/5/2023	IVD (In Vitro Diagnostics)	Slides	Transcript
Clinical Laboratory Improvement Amendments (CLIA)	Webinar	3/24/2014	IVD (In Vitro Diagnostics), CLIA (Clinical Laboratory Improvement Amendments)	Slides	Transcript
Clinical Laboratory Improvement Amendments of 1998 (CLIA) Waiver Applications Final Guidances	Webinar	4/14/2020	IVD (In Vitro Diagnostics), CLIA (Clinical Laboratory Improvement Amendments)	Slides	Transcript
Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices	Webinar	2/12/2019	IVD (In Vitro Diagnostics)	Slides	Transcript
Electromagnetic Compatibility (EMC) of In Vitro Diagnostic Devices	Webinar	2/2/2023	IVD (In Vitro Diagnostics)	Slides	Transcript
Enforcement Policies for Certain In Vitro Diagnostic Devices - Draft Guidances	Webinar	6/5/2024	IVD (In Vitro Diagnostics)	Slides	Transcript
Final Guidances on Next Generation Sequencing-based Tests	Webinar	5/24/2018	IVD (In Vitro Diagnostics)	Slides	Transcript
In Vitro Diagnostic Product (IVD) Classification	Webinar	7/16/2024	IVD (In Vitro Diagnostics)	Slides	Transcript
In Vitro Diagnostic Products (IVDs) - MDR Requirements, Correction and Removal Reporting Requirements, and Quality System Complaint Requirements	Webinar	8/22/2024	IVD (In Vitro Diagnostics), MDR (Medical Device Reporting), Correction, Removal, QMSR (Quality Management System Regulation)	Slides	Transcript
Labeling Requirements for In Vitro Diagnostic Products (IVD), Including LDTs, Under 21 CFR 809.10(b)	Webinar	9/24/2024	IVD (In Vitro Diagnostics)	Slides	Transcript
Laboratory Developed Tests; Medical Devices: Final Rule	Webinar	5/14/2024	IVD (In Vitro Diagnostics)	Slides	Transcript
Laboratory Developed Tests; Medical Devices: Proposed Rule	Webinar	10/31/2023	IVD (In Vitro Diagnostics)	Slides	Transcript
Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program	Webinar	12/12/2023	IVD (In Vitro Diagnostics)	Slides	Transcript
Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product	Webinar	8/18/2016	IVD (In Vitro Diagnostics)	Slides	Transcript
Registration & Listing Requirements for In Vitro Diagnostic Products (IVDs), Including Laboratory Developed Tests (LDTs)	Webinar	12/3/2024	IVD (In Vitro Diagnostics), Registration and Listing	Slides	Transcript
Total Product Life Cycle Approach to In Vitro Diagnostic Products (IVDs)	Webinar	10/24/2024	IVD (In Vitro Diagnostics)	Slides	Transcript
IVD Virtual Town Hall Series 0	Town Hall	3/2/2020	IVD (In Vitro Diagnostics), COVID-19	Slides	Transcript
IVD Virtual Town Hall Series 00	Town Hall	3/6/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 01	Town Hall	3/25/2020	IVD (In Vitro Diagnostics), COVID-19	Slides	Transcript
IVD Virtual Town Hall Series 02	Town Hall	4/1/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 03	Town Hall	4/8/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 04	Town Hall	4/15/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 05	Town Hall	4/22/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 06	Town Hall	4/29/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 07	Town Hall	5/6/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 08	Town Hall	5/13/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 09	Town Hall	5/20/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 10	Town Hall	5/27/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 11	Town Hall	6/3/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 12	Town Hall	6/10/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 13	Town Hall	6/17/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 14	Town Hall	6/24/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 15	Town Hall	7/1/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 16	Town Hall	7/8/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 17	Town Hall	7/15/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 18	Town Hall	7/22/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 19	Town Hall	7/29/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 20	Town Hall	8/5/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 21	Town Hall	8/12/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 22	Town Hall	8/19/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 23	Town Hall	8/26/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 24	Town Hall	9/2/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 25	Town Hall	9/9/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 26	Town Hall	9/16/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 27	Town Hall	9/23/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 28	Town Hall	9/30/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 29	Town Hall	10/7/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 30	Town Hall	10/14/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 31	Town Hall	10/21/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 32	Town Hall	10/28/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 33	Town Hall	11/4/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 34	Town Hall	11/18/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 35	Town Hall	12/2/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 36	Town Hall	12/9/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 37	Town Hall	12/16/2020	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 38	Town Hall	1/6/2021	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 39	Town Hall	1/13/2021	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 40	Town Hall	1/27/2021	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 41	Town Hall	2/3/2021	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 42	Town Hall	2/10/2021	IVD (In Vitro Diagnostics), COVID-19	Slides	Transcript
IVD Virtual Town Hall Series 43	Town Hall	2/17/2021	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 44	Town Hall	2/24/2021	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 45	Town Hall	3/3/2021	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 46	Town Hall	3/10/2021	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 47	Town Hall	3/17/2021	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 48	Town Hall	3/24/2021	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 49	Town Hall	3/31/2021	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 50	Town Hall	4/7/2021	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 51	Town Hall	4/14/2021	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 52	Town Hall	4/21/2021	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 53	Town Hall	4/28/2021	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 54	Town Hall	5/5/2021	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 55	Town Hall	5/12/2021	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 56	Town Hall	5/19/2021	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 57	Town Hall	5/26/2021	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 58	Town Hall	6/2/2021	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 59	Town Hall	6/9/2021	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 60	Town Hall	6/16/2021	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 61	Town Hall	6/23/2021	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 62	Town Hall	6/30/2021	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 63	Town Hall	7/14/2021	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 64	Town Hall	7/28/2021	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 65	Town Hall	8/4/2021	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 66	Town Hall	8/11/2021	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 67	Town Hall	8/18/2021	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 68	Town Hall	8/25/2021	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 69	Town Hall	9/8/2021	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 70	Town Hall	9/22/2021	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 71	Town Hall	10/6/2021	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 72	Town Hall	10/20/2021	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 73	Town Hall	11/17/2021	IVD (In Vitro Diagnostics), COVID-19	Slides	Transcript
IVD Virtual Town Hall Series 74	Town Hall	12/1/2021	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 75	Town Hall	12/15/2021	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 76	Town Hall	1/12/2022	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 77	Town Hall	1/26/2022	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 78	Town Hall	2/9/2022	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 79	Town Hall	2/23/2022	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 80	Town Hall	3/9/2022	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 81	Town Hall	3/23/2022	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 82	Town Hall	4/6/2022	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 83	Town Hall	4/20/2022	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 84	Town Hall	5/4/2022	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 85	Town Hall	5/18/2022	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 86	Town Hall	6/1/2022	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 87	Town Hall	6/15/2022	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 88	Town Hall	6/29/2022	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 89	Town Hall	7/27/2022	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 90	Town Hall	8/24/2022	IVD (In Vitro Diagnostics), COVID-19		Transcript
IVD Virtual Town Hall Series 91	Town Hall	9/14/2022	IVD (In Vitro Diagnostics), Monkeypox (mpox)	Slides	Transcript
IVD Virtual Town Hall Series 92	Town Hall	9/21/2022	IVD (In Vitro Diagnostics), Monkeypox (mpox)		Transcript
IVD Virtual Town Hall Series 93	Town Hall	9/28/2022	IVD (In Vitro Diagnostics), COVID-19, Monkeypox (mpox)	Slides	Transcript
IVD Virtual Town Hall Series 94	Town Hall	10/5/2022	IVD (In Vitro Diagnostics), Monkeypox (mpox)		Transcript
IVD Virtual Town Hall Series 95	Town Hall	10/12/2022	IVD (In Vitro Diagnostics), Monkeypox (mpox)		Transcript
IVD Virtual Town Hall Series 96	Town Hall	10/26/2022	IVD (In Vitro Diagnostics), COVID-19, Monkeypox (mpox)		Transcript
IVD Virtual Town Hall Series 97	Town Hall	11/9/2022	IVD (In Vitro Diagnostics), Monkeypox (mpox)		Transcript
IVD Virtual Town Hall Series 98	Town Hall	11/30/2022	IVD (In Vitro Diagnostics), COVID-19, Monkeypox (mpox)		Transcript
IVD Virtual Town Hall Series 99	Town Hall	12/14/2022	IVD (In Vitro Diagnostics), COVID-19, Monkeypox (mpox)		Transcript
IVD Virtual Town Hall Series 100	Town Hall	1/11/2023	IVD (In Vitro Diagnostics), COVID-19, Monkeypox (mpox)	Slides	Transcript
IVD Virtual Town Hall Series 101	Town Hall	2/15/2023	IVD (In Vitro Diagnostics), COVID-19, Monkeypox (mpox)	Slides	Transcript
IVD Virtual Town Hall Series 102	Town Hall	3/22/2023	IVD (In Vitro Diagnostics), COVID-19, Monkeypox (mpox)	Slides	Transcript
IVD Virtual Town Hall Series 103	Town Hall	4/26/2023	IVD (In Vitro Diagnostics), COVID-19	Slides	Transcript
Unique Device Identification (UDI) System Regulatory Overview	Module	1/27/2016	UDI (Unique Device Identification), GUDID (Global Unique Device Identification Database)	Slides	Transcript
Global Unique Device Identification Database (GUDID) Account Request: Preparation and Process	Module	1/27/2016	UDI (Unique Device Identification), GUDID (Global Unique Device Identification Database)	Slides	Transcript
The GUDID Device Identifier (DI) Record	Module	3/10/2016	UDI (Unique Device Identification), GUDID (Global Unique Device Identification Database)	Slides	Transcript
GUDID HL7 SPL Submission Option	Module	3/10/2016	UDI (Unique Device Identification), GUDID (Global Unique Device Identification Database)	Slides	Transcript
Optimizing GUDID Data Quality	Webinar	8/3/2017	UDI (Unique Device Identification), GUDID (Global Unique Device Identification Database)	Slides	Transcript
Unique Device Identification: Direct Marking of Devices Final Guidance	Webinar	11/30/2017	UDI (Unique Device Identification), GUDID (Global Unique Device Identification Database)	Slides	Transcript
Unique Device Identification: Convenience Kits, Final Guidance	Webinar	5/21/2019	UDI (Unique Device Identification), GUDID (Global Unique Device Identification Database), Convenience Kit	Slides	Transcript
COVID-19 Transition Policy for Devices, Final Guidances	Webinar	4/27/2023	COVID-19	Slides	Transcript
Dental Devices Premarket Submissions	Webinar	10/2/2019	Dental Devices, 510(k) (Premarket Notification), MDR (Medical Device Reporting)	Slides	Transcript
Hearing Aids and Personal Sound Amplification Products	Webinar	12/1/2021	Hearing Aids	Slides	Transcript
Refresh on General Wellness: Policy for Low-Risk Devices	Town Hall	2/13/2026	General Wellness	Slides	Transcript
Self monitoring blood glucose tests for over the counter use and Blood glucose monitoring test systems for prescription point of care use	Webinar	11/21/2016	IVD (In Vitro Diagnostics)	Slides	Transcript
Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) Final Guidance	Webinar	4/23/2019	Animal-Related	Slides	Transcript
Toxicological Risk Assessment Approaches for Addressing Biocompatibility Endpoints	Town Hall	10/7/2026	Biocompatibility	Slides	Transcript
Extractions for Conducting Chemical Analysis for Biocompatibility Assessment	Town Hall	9/23/2026	Biocompatibility	Slides	Transcript
Risk Assessment Approaches for Addressing Biocompatibility Endpoints	Town Hall	9/17/2026	Biocompatibility	Slides	Transcript
Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process” - Final Guidance [2023]	Webinar	10/11/2023	Biocompatibility	Slides	Transcript
Final Guidance on "Use of International Standard ISO 10993-1, Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process" [2016]	Webinar	7/21/2016	Biocompatibility	Slides	Transcript
Color Additives and the Medical Device Review	Webinar	2/18/2016	Biocompatibility	Slides	Transcript
Collaborative Communities: Addressing Healthcare Challenges Together	Webinar	10/29/2019	Collaborative Communities	Slides	Transcript
Custom Device Exemption	Module	11/27/2019	Custom Device	Slides	Transcript
Technical Considerations for Additive Manufactured Medical Devices	Webinar	1/10/2018	Custom Device, Additive Manufacturing	Slides	Transcript
Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act: Final Guidance	Webinar	11/14/2019	Digital Health, Software	Slides	Transcript
Clinical Decision Support Software, Final Guidance	Town Hall	3/13/2026	Digital Health, Software	Slides	Transcript
Content of Premarket Submissions for Device Software Functions, Final Guidance	Webinar	7/20/2023	Digital Health, Software	Slides	Transcript
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions – Final Guidance	Webinar	11/1/2023	Digital Health, Cybersecurity	Slides	Transcript
Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices	Webinar	10/26/2017	Digital Health, Interoperability	Slides	Transcript
Digital Health	Webinar	2/24/2015	Digital Health	Slides	Transcript
Digital Health Center of Excellence Listening Session #1	Webinar	10/19/2020	Digital Health	Slides	Transcript
Digital Health Center of Excellence Listening Session #2	Webinar	11/12/2020	Digital Health	Slides	Transcript
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions, Final Guidance	Webinar	1/13/2025	Digital Health, PCCP (Predetermined Change Control Plans), Artificial Intelligence	Slides	Transcript
Postmarket Management of Cybersecurity in Medical Devices Final Guidance	Webinar	1/12/2017	Digital Health, Cybersecurity	Slides	Transcript
Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot	Module	2/3/2026	Digital Health	Slides	Transcript
Reducing Readmissions through Device Innovation for the Home (READI-Home) Innovation Challenge	Webinar	7/9/2026	Home Use	Slides	Transcript
FDA's Home Use Medical Device Initiative	Module	7/22/2011	Home Use	Slides
Promoting Patient Safety with Home Use Devices	Module	7/22/2011	Home Use	Slides
Home Use Medical Devices: New Risks	Module	7/22/2011	Home Use	Slides
Medical Devices in the Home: Design Considerations and Guidance for Industry	Webinar	9/9/2014	Home Use	Slides	Transcript
Applying Human Factors and Usability Engineering to Medical Devices	Webinar	2/19/2016	Human Factors	Slides	Transcript
Content of Human Factors Information in Medical Device Marketing Submissions, Final Guidance	Town Hall	7/30/2026	Human Factors	Slides	Transcript
Introduction to Medical Device Development Tools (MDDTs)	Module	9/16/2026	MDDT (Medical Device Development Tools)	Slides	Transcript
Qualification of Medical Device Development Tools	Webinar	9/8/2023	MDDT (Medical Device Development Tools)	Slides	Transcript
Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment	Webinar	6/24/2021	Medical Imaging	Slides	Transcript
Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder: Draft Guidance	Webinar	9/8/2023	Neurological Devices, Clinical Studies	Slides	Transcript
Regulatory Overview for Developers and Sponsors of Neurological Devices: An Introduction to Humanitarian Device Exemptions (HDEs)	Webinar	12/18/2017	Neurological Devices, HDE (Humanitarian Device Exemption)	Slides	Transcript
Implanted BCI Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations Final Guidance	Webinar	7/29/2021	Neurological Devices, Clinical Studies	Slides	Transcript
Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation, Final Guidance	Webinar	2/1/2022	Patient Engagement	Slides	Transcript
Patient Engagement in the Design and Conduct of Medical Device Clinical Studies, Final Guidance	Webinar	3/22/2022	Patient Engagement	Slides	Transcript
Enforcement Policy for Personal Protective Equipment (PPE) During COVID-19: Immediately in Effect Guidance - April 6, 2020	Webinar	4/6/2020	PPE (Personal Protective Equipment), COVID-19	Slides	Transcript
Respirators for Healthcare Personnel Use During COVID-19 Pandemic - June 9, 2020	Webinar	6/9/2020	PPE (Personal Protective Equipment), COVID-19	Slides	Transcript
Respirators for Healthcare Personnel Use During COVID-19 Pandemic - June 23, 2020	Webinar	6/23/2020	PPE (Personal Protective Equipment), COVID-19	Slides	Transcript
Respirators for Healthcare Personnel Use During COVID-19 Pandemic - July 7, 2020	Webinar	7/16/2020	PPE (Personal Protective Equipment), COVID-19	Slides	Transcript
Respirators for Healthcare Personnel Use During COVID-19 Pandemic - July 21, 2020	Webinar	7/30/2020	PPE (Personal Protective Equipment), COVID-19		Transcript
Regulation of Face Masks and Surgical Masks During the COVID-19 Pandemic - August 4, 2020	Webinar	8/4/2020	PPE (Personal Protective Equipment), COVID-19		Transcript
FDA’s Surgical Masks Umbrella EUA - August 18, 2020	Webinar	8/27/2020	PPE (Personal Protective Equipment), COVID-19		Transcript
CDC/NIOSH's Surgical N95 Respirator Guidance - September 1, 2020	Webinar	9/1/2020	PPE (Personal Protective Equipment), COVID-19	Slides	Transcript
Gowns and Other Apparel for Use by Health Care Personnel in COVID-19 Pandemic	Webinar	9/15/2020	PPE (Personal Protective Equipment), COVID-19	Slides	Transcript
Respirators and Other PPE for Health Care Personnel Use	Webinar	10/14/2020	PPE (Personal Protective Equipment), COVID-19		Transcript
Protective Barrier Enclosure Emergency Use Authorizations (EUAs)	Webinar	10/23/2020	PPE (Personal Protective Equipment), COVID-19	Slides	Transcript
Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic [510(k) Review for Surgical Mask]	Webinar	10/27/2020	PPE (Personal Protective Equipment), COVID-19	Slides	Transcript
Gowns - Regulatory Responsibilities [Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care]	Webinar	1/21/2016	PPE (Personal Protective Equipment), COVID-19	Slides	Transcript
Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic [Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff]	Webinar	12/8/2020	PPE (Personal Protective Equipment), COVID-19	Slides	Transcript
Enforcement Policy for Bioburden Reduction Systems Using Dry Heat to Support Single-User Reuse of Certain Filtering Facepiece Respirators during the COVID-19 Pandemic	Webinar	1/26/2021	PPE (Personal Protective Equipment), COVID-19	Slides	Transcript
Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic [Updated Information on Respirator Decontamination Systems]	Webinar	2/23/2021	PPE (Personal Protective Equipment), COVID-19	Slides	Transcript
Transitioning from the Use of Decontaminated Disposable Respirators	Webinar	4/26/2021	PPE (Personal Protective Equipment), COVID-19	Slides	Transcript
Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic	Webinar	6/8/2021	PPE (Personal Protective Equipment), COVID-19	Slides
Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic [Respirator Update: FDA no Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators]	Webinar	7/13/2021	PPE (Personal Protective Equipment), COVID-19	Slides	Transcript
Targeted Box and Blocks Test (tBBT)	Module	12/13/2022	Regulatory Science Tools		Transcript
Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions, Final Guidance	Webinar	1/10/2024	Regulatory Science Tools	Slides	Transcript
Duodenoscope Sampling and Culturing	Webinar	3/22/2018	Reprocessing	Slides	Transcript
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling	Webinar	3/24/2015	Reprocessing	Slides	Transcript
FDA Innovation Challenges: Identify Sterilization Alternatives and Reduce Ethylene Oxide Emissions	Webinar	8/13/2019	Sterilization	Slides	Transcript
Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile Final Guidance	Webinar	2/22/2016	Sterilization, 510(k) (Premarket Notification)	Slides	Transcript
Medical Device Sterilization Town Hall 01: Overview	Town Hall	1/10/2024	Sterilization	Slides	Transcript
Medical Device Sterilization Town Hall 02: FDA’s Sterilization Related Activities	Town Hall	1/26/2024	Sterilization	Slides	Transcript
Medical Device Sterilization Town Hall 03: Premarket Part 1 New submissions & considerations	Town Hall	2/7/2024	Sterilization	Slides	Transcript
Medical Device Sterilization Town Hall 04: Premarket Part 2 Modifications and Master Files	Town Hall	2/29/2024	Sterilization	Slides	Transcript
Medical Device Sterilization Town Hall 05: Premarket Part 3 Use of Standards & Standards Development	Town Hall	3/21/2024	Sterilization	Slides	Transcript
Medical Device Sterilization Town Hall 06: Topics and Formats for the Continuing Town Hall Series	Town Hall	4/29/2024	Sterilization	Slides	Transcript
Medical Device Sterilization Town Hall 07: Sterilization Method Selection	Town Hall	5/23/2024	Sterilization	Slides	Transcript
Medical Device Sterilization Town Hall 08: Sterilization Open Q&A	Town Hall	6/12/2024	Sterilization	Slides	Transcript
Medical Device Sterilization Town Hall 09: Mock Pre-Submission for Sterilization Method Change	Town Hall	7/10/2024	Sterilization	Slides	Transcript
Medical Device Sterilization Town Hall 10: Bioburden, bacterial endotoxin and packaging integrity testing for sterile medical devices	Town Hall	8/7/2024	Sterilization	Slides	Transcript
Medical Device Sterilization Town Hall 11: Effective use of Sterility Master Files	Town Hall	9/11/2024	Sterilization	Slides	Transcript
Medical Device Sterilization Town Hall 12: Predetermined Change Control Plans (PCCPs)	Town Hall	10/9/2024	Sterilization	Slides	Transcript
Medical Device Sterilization Town Hall 13: Supporting medical device innovators and bundling sterility submissions	Town Hall	10/30/2024	Sterilization	Slides	Transcript
Medical Device Sterilization Town Hall 14: Recognized consensus standards and biocompatibility assessment considerations	Town Hall	11/20/2024	Sterilization	Slides	Transcript
Medical Device Sterilization Town Hall 15: New transitional enforcement policy, VH2O2 diffusion research/modeling, series updates, wrap up and next steps	Town Hall	12/4/2024	Sterilization	Slides	Transcript
How to Get Your Electronic Product on the U.S. Market	Module	10/16/2018	Radiation-Emitting Products	Slides	Transcript
Electronic Product Certification and Quality Testing Programs	Module	1/13/2020	Radiation-Emitting Products	Slides	Transcript
Marketing Clearance of Diagnostic Ultrasound Systems and Transducers: Final Guidance	Webinar	8/22/2019	Radiation-Emitting Products	Slides	Transcript
Pediatric Information for X-ray Imaging Device Premarket Notifications	Webinar	1/9/2018	Radiation-Emitting Products	Slides	Transcript
Phantom Image Scoring (for MQSA Inspectors)	Module	1/31/2011	Radiation-Emitting Products, MQSA (Mammography Quality Standards Act)
eSubmitter Tutorial Presentations	Other		Radiation-Emitting Products, eSubmitter
Creating a Radiological Health Report Using eSubmitter	Module		Radiation-Emitting Products, eSubmitter
510(k) Third Party Review Program: Overview	Module	10/16/2018	Third Party Review, 510(k) (Premarket Notification)		Transcript
X-Ray Systems: Third Party Reviewer	Module	10/16/2018	Third Party Review, Radiation-Emitting Products	Slides	Transcript
510(k) Third Party Review Program: Final Guidance	Webinar	4/16/2020	Third Party Review, 510(k) (Premarket Notification)	Slides	Transcript
Overview of the 510(k) Process: Guide for Third Party Reviewers	Module	2/12/2020	Third Party Review, 510(k) (Premarket Notification)	Slides	Transcript
November 2022 Industry Basics Workshop: Understanding Risk Management with Medical Devices	Workshop	11/1/2022	QMSR (Quality Management System Regulation)
April 2021 Industry Basics Workshop: Consensus Standards and the Accreditation Scheme for Conformity Assessment (ASCA) Pilot	Workshop	4/13/2021	Standards, ASCA (Accreditation Scheme for Conformity Assessment)
November 2019 Industry Basics Workshop: 513(g) Requests for Information and Custom Device Exemption	Workshop	11/29/2019	513(g) (Request for Classification), Custom Device
March 2016 Industry Basics Workshop: Unique Device Identification (UDI) Part II, Submitting Information to GUDID	Workshop	3/1/2016	UDI (Unique Device Identification), GUDID (Global Unique Device Identification Database)
January 2016 Industry Basics Workshop: Unique Device Identification (UDI) Part I	Workshop	1/1/2016	UDI (Unique Device Identification), GUDID (Global Unique Device Identification Database)

Contact Us

Office of Industry and Consumer Education
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993

AskOICE@fda.hhs.gov

(800) 638-2041
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Device Advice

Device Advice is CDRH's premier text-based resource for comprehensive regulatory education that explains medical device laws, regulations, guidances, and policies, across the entire product life cycle.

CDRH Webinars

CDRH Webinars feature FDA presentations and live stakeholder question and answer discussions about timely medical device laws, regulations, guidances, or programs.