CDRH Learn

Welcome to CDRH Learn! CDRH Learn is our multi-media educational resource, featuring learning modules that address medical device and radiation emitting product laws, regulations, guidances, and policies, across the entire product life cycle. These modules provide industry with information that is comprehensive, interactive, and easily accessible. Modules are provided in various formats, including videos, audio recordings, and slide presentations. 

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Start Here/The Basics! (Updated 10/29/2024)

MDUFA Small Business Program, Registration and Listing

An Introduction to FDA's Regulation of Medical Devices 
Presentation   Printable Slides   Transcript

How is CDRH Structured?
Presentation   Printable Slides   Transcript

Is My Product a Medical Device?
Presentation   Printable Slides   Transcript

An Introduction to the Medical Device User Fee Program: MDUFA V
Presentation  Printable Slides  Transcript

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MDUFA Small Business Program

For information about submissions to the Small Business Determination (SBD) program, please reference "How to submit a Small Business Certification Request".

How to Complete Form FDA 3602: MDUFA Small Business Qualification and Certification for a Business Headquartered in the United States. 

Presentation   Transcript

How to Complete Form FDA 3602A: MDUFA Foreign Small Business Certification Request for a Business Headquartered Outside the United States. 

Presentation   Transcript

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Registration and Listing

Device Registration and Listing: An Introduction – Part 1
Presentation   Printable Slides   Transcript

Device Registration and Listing: An Introduction – Part 2
Presentation   Printable Slides   Transcript

Paying the Annual Registration User Fee via the Device Facility User Fee (DFUF) Website
Presentation   Printable Slides

FURLS Device Registration and Listing Module for Annual Registration
Presentation

FURLS Device Registration and Listing Module for Initial Registration
Presentatio

How to Study and Market Your Device - (New module 10/18/24)

510k, De Novo, IDE, PMA, HUD/HDE, Q-Submissions, Standards, Classification

Premarket Notification (510k)

The 510(k) Program
Presentation   Printable Slides   Transcript

CDRH's New Draft Guidances to Continue to Modernize the 510(k) Program

Presentation   Printable Slides   Transcript

The Special 510(k) Program: Final Guidance
Presentation   Printable Slides   Transcript

Safety and Performance Based Pathway Criteria for Certain Device Types Final Guidances
Presentation   Printable Slides   Transcript

Safety and Performance Based Pathway Performance Criteria
Presentation   Printable Slides   Transcript

Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics
Presentation   Printable 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" 
Presentation   Printable Slides   Transcript

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De Novo

De Novo Final Rule: Overview and Guidance Updates
Presentation   Printable Slides   Transcript

De Novo Program
Presentation   Printable Slides   Transcript

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Clinical Studies/Investigational Device Exemption (IDE)

IDE Basics
Presentation   Printable Slides   Transcript

Implementation of Final Rule on Human Subject Protection: Acceptance of Data from Clinical Investigations for Medical Devices
Printable Slides    Survey

Final Guidance on Adaptive Designs for Medical Device Clinical Studies
Presentation   Printable Slides   Transcript

An Update on the FDA's Medical Device Clinical Trials Program
Presentation    Printable Slides (Full, Part 1, Part 2)    Transcript

Breakthrough Devices Program, Updated Final Guidance [2023]
Presentation     Printable Slides    Transcript

Breakthrough Devices Program [2019]
Presentation   Printable Slides   Transcript

Strengthening the Medical Device Clinical Trial Enterprise
Presentation   Printable Slides   Transcript

IDEs for Early Feasibility Medical Device Clinical Studies, Including First in Human (FIH) Studies
Presentation   Printable Slides   Transcript

FDA Guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices
Presentation   Printable Slides   Transcript

Evaluation of Sex-Specific Data in Medical Device Clinical Studies
Presentation   Printable Slides   Transcript

FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations
Presentation   Printable Slides   Transcript

Clinical Studies/IDE  
Presentation   Printable Slides   Transcript

Post-Approval Study Requirements and Postmarket Surveillance under Section 522 of the Federal Food, Drug, and Cosmetic Act, Final Guidances
Presentation   Printable Slides   Transcript

FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions
Presentation   Printable Slides   Transcript

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Premarket Approval Application (PMA)

Introduction to the Premarket Approval Application (PMA) Program
Presentation   Printable Slides   Transcript

Premarket Approval Application (PMA) Program: Postapproval Requirements
Presentation   Printable Slides   Transcript

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Humanitarian Use Device (HUD)/Humanitarian Device Exemption (HDE) 

Module 1: Office of Orphan Products Development
Presentation   Printable Slides   Transcript

Module 2: Humanitarian Use Device (HUD): Program Overview
Presentation   Printable Slides   Transcript

Module 3: Humanitarian Device Exemption (HDE): Program Overview and Pre-approval Activities
Presentation   Printable Slides   Transcript

Module 4: Humanitarian Device Exemption (HDE): Post-approval Activities
Presentation   Printable Slides   Transcript

Humanitarian Device Exemption Program
Presentation   Printable Slides   Transcript

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Q-Submissions

Q-Submission Program for Medical Device Submissions
Presentation   Printable Slides   Transcript

Requests for Feedback: The Pre-Submission Program and Meetings with FDA Staff
Presentation   Printable Slides   Transcript

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Standards 

Module 1: Standards Overview
Presentation   Printable Slides   Transcript

Module 2: Standards Resources and Premarket Use
Presentation   Printable Slides   Transcript

Module 3: CDRH Standards Recognition Process
Presentation   Printable Slides   Transcript

Module 4: How to Use Consensus Standards in Premarket Submissions
Presentation   Printable Slides   Transcript

Module 5: The ASCA Pilot: Streamlining Conformity Assessment in Device Submissions 
Presentation   Printable Slides   Transcript

Webinar - ASCA Pilot: Streamlining Conformity Assessment in Device Submissions
Presentation   Printable Slides   Transcript

Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Final Guidances
Presentation   Printable Slides   Transcript

Appropriate Use of Voluntary Consensus Standards
Presentation   Printable Slides   Transcript

Recognition and Withdrawal of Voluntary Consensus Standards - Final Guidance
Presentation   Printable Slides   Transcript

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Cross-Cutting Premarket Policy

CDRH Portal Overview and Feature Walkthrough
Presentation   Printable Slides   Transcript

Combination Product Updates for "Acceptance and Filing Reviews for Premarket Approval Applications" and "Refuse to Accept Policy for 510(k)s" 
Presentation   Printable Slides   Transcript

Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions
Presentation   Printable Slides   Transcript

Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications
Presentation   Printable Slides   Transcript

Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle, Draft Guidance (Updated 10/18/2024)
Presentation  Printable Slides   Transcript

The Least Burdensome Provisions: Concept and Principles Final Guidance
Presentation   Printable Slides   Transcript

Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices
Presentation   Printable Slides   Transcript

Multiple Function Device Products: Policy and Considerations
Presentation   Printable Slides   Transcript

Patient Preference Information 
Presentation   Printable Slides   Transcript

Predetermined Change Control Plans for Medical Devices, Draft Guidance (Updated 9/11/24)
Presentation   Printable Slides   Transcript

Safer Technologies Program: Draft Guidance
Printable Slides

Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
Presentation   Printable Slides   Transcript

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Classification

How is My Medical Device Classified?
Presentation   Printable Slides   Transcript

Case Study: How is My Medical Device Classified?
Presentation   Printable Slides   Transcript

513(g) Requests for Information
Presentation   Printable Slides   Transcript

Final Guidance on Medical Device Accessories: Describing Accessories and Classification Pathway for New Accessory Types 
Presentation   Printable Slides   Transcript

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Bioresearch Monitoring (BIMO)

BIMO Part 1 - Introduction to the Bioresearch Monitoring Program
Presentation   Printable Slides

BIMO Part 3a - Institutional Review Board: Responsibilities in Making the Significant Risk and Non-significant Risk Device Determination
Presentation   Printable Slides

BIMO Part 3b - Institutional Review Board: Humanitarian Use Devices (HUDs)
Presentation   Printable Slides

BIMO Part 4c - Preparing for an FDA Institutional Review Board Inspection
Presentation   Printable Slides

BIMO Part 5a - Strategies for Sponsors to Build Quality into Device Research
Presentation   Printable Slides

BIMO Part 5b - Strategies For Clinical Investigators to Build Quality into Device Research
Presentation   Printable Slides

Postmarket Activities (Updated module 10/16/24)

Quality System, QMSR, Exporting, Device Recalls, MDR, Inspection - Global Harmonization

Overview of the Quality System 

Start Here! Overview of the Quality System
Presentation   Printable Slides   Transcript

Production and Process Controls
Presentation   Printable Slides   Transcript

Production and Process Controls, Part 2
Presentation   Printable Slides   Transcript

Documents, Change Control, and Records
Presentation   Printable Slides   Transcript

Design Controls 
Presentation   Printable Slides   Transcript

Risk Basics for Medical Devices 
Presentation   Printable Slides   Transcript

Application of Risk Management Principles for Medical Devices 
Presentation   Printable Slides   Transcript

Management Controls 
Presentation   Printable Slides   Transcript

Purchasing Controls
Presentation   Printable Slides   Transcript

Process Validation
Presentation   Printable Slides   Transcript

Corrective and Preventive Actions
Presentation   Printable Slides   Transcript

Nonconforming Product
Presentation   Printable Slides   Transcript

Complaint Files
Presentation   Printable Slides   Transcript

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Quality Management System Regulation (New section)

Overview of Quality Management System Regulation (New 8/30/24)
Presentation   Printable Slides   Transcript

Navigating the Quality Management System Regulation (New 8/30/24)
Presentation   Printable Slides   Transcript

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Exports and Imports

Exporting Medical Devices
Presentation   Printable Slides   Transcript

Importing Medical Devices Into the United States
Presentation   Printable Slides   Transcript

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General Policy

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
Presentation   Printable Slides   Transcript

Final Guidance: Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance and Enforcement Decisions
Presentation   Printable Slides   Transcript

Remanufacturing of Medical Devices, Final Guidance (Updated 9/17/24)
Presentation   Printable Slides   Transcript

Computer Software Assurance for Production and Quality System Software, Draft Guidance
Presentation   Printable Slides   Transcript

Voluntary Improvement Program (Updated 10/16/24)
Presentation   Printable Slides   Transcript

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Medical Device Recalls

Introduction to Medical Device Recalls
Presentation   Printable Slides   Transcript

Distinguishing Medical Device Recalls from Medical Device Enhancements
Presentation   Printable Slides   Transcript

Recall Module 21 CFR Part 806: Medical Devices; Reports of Corrections and Removals
Presentation   Printable Slides

Electronic Submission of 806 Reports of Corrections and Removals
Printable Slides

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Medical Device Reporting (MDR)

Overview of Medical Device Reporting
Presentation   Printable Slides   Transcript

Medical Device Reporting for Mandatory Reporters
Presentation   Printable Slides   Transcript

Electronic Medical Device Reporting (eMDR)
Presentation   Printable Slides   Transcript

Final Guidance on Medical Device Reporting for Manufacturers 
Presentation   Printable Slides   Transcript

eMDR eSubmitter and WebTrader Tutorial
Presentation   Transcript

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Inspections - Global Harmonization

(1A) Introduction to the MDSAP Program
Printable Slides   Transcript

(1B) Overview of the MDSAP Audit Process
Printable Slides   Transcript

(2) MDSAP: Management Process
Printable Slides   Transcript

(3) MDSAP: Device Marketing Authorization and Facility Registration
Printable Slides   Transcript

(4) MDSAP: Measurement, Analysis and Improvement Process 
Printable Slides   Transcript

(5) MDSAP: Medical Device Adverse Events and Advisory Notices Reporting Process
Printable Slides   Transcript

(6) MDSAP: Design and Development Process
Printable Slides   Transcript

(7) MDSAP: Production and Service Controls Process, Part 1
Printable Slides   Transcript

(8) MDSAP: Production and Service Controls Process: Part 2
Printable Slides   Transcript

(9) MDSAP: Production and Service Controls Process: Part 3
Printable Slides   Transcript

(10) MDSAP: Purchasing Process 
Printable Slides Transcript

In Vitro Diagnostics - (Updated 12/06/24)

IVD Development, CLIA, and Virtual Town Hall Series

3D Printed Swabs
Presentation   Printable Slides   Transcript

Antimicrobial Susceptibility Test System Devices - Updating Breakpoints in Device Labeling
Presentation   Printable Slides   Transcript

CLIA Waiver Applications Draft Guidances
Presentation   Printable Slides   Transcript

Clinical Laboratory Improvement Amendments (CLIA)
Presentation   Printable Slides   Transcript

Clinical Laboratory Improvement Amendments (CLIA) Waiver Applications Final Guidances
Presentation   Printable Slides   Transcript

Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices
Presentation   Printable Slides   Transcript

Electromagnetic Compatibility (EMC) of In Vitro Diagnostic Devices
Presentation   Printable Slides   Transcript

Enforcement Policies for Certain In Vitro Diagnostic Devices - Draft Guidances (Updated 6/11/2024)
Presentation   Printable Slides   Transcript

Final Guidances on Next Generation Sequencing-based Tests
Presentation   Printable Slides   Transcript

In Vitro Diagnostic Product (IVD): Classification (Updated 8/18/2024)
Presentation   Printable Slides   Transcript

In Vitro Diagnostic Products (IVDs) - MDR Requirements, Correction and Removal Reporting Requirements, and Quality System Complaint Requirements (Updated 8/27/2024)
Presentation  Printable Slides   Transcript

Labeling Requirements for In Vitro Diagnostic Products (IVD), Including LDTs, Under 21 CFR 809.10(b) (Updated 9/27/2024)
Presentation   Printable Slides   Transcript

Laboratory Developed Tests; Medical Devices: Final Rule (Updated 5/20/24)
Presentation   Printable Slides   Transcript

Laboratory Developed Tests; Medical Devices: Proposed Rule
Presentation   Printable Slides   Transcript

Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program
Presentation   Printable Slides   Transcript

Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product
Presentation   Printable Slides   Transcript

Registration & Listing Requirements for In Vitro Diagnostic Products (IVDs), Including Laboratory Developed Tests (LDTs) (Updated 12/06/2024)
Presentation   Printable Slides  Transcript

Total Product Life Cycle Approach to In Vitro Diagnostic Products (IVDs) (Updated 10/29/2024)
Presentation  Printable Slides    Transcript

Virtual Town Hall Series

Series Number	Topic	Date	Materials
0		03/02/2020	Presentation   Transcript   Slides
00		03/06/2020	Transcript
01		03/25/2020	Presentation   Transcript   Slides
02		04/01/2020	Presentation   Transcript
03		04/08/2020	Presentation   Transcript
04		04/15/2020	Presentation   Transcript
05		04/22/2020	Presentation   Transcript
06		04/29/2020	Presentation   Transcript
07		05/06/2020	Presentation   Transcript
08		05/13/2020	Presentation   Transcript
09		05/20/2020	Presentation   Transcript
10		05/27/2020	Presentation   Transcript
11		06/03/2020	Presentation   Transcript
12		06/10/2020	Presentation   Transcript
13		06/17/2020	Presentation   Transcript
14		06/24/2020	Presentation   Transcript
15		07/01/2020	Presentation   Transcript
16		07/08/2020	Presentation   Transcript
17		07/15/2020	Presentation   Transcript
18		07/22/2020	Presentation   Transcript
19		07/29/2020	Presentation   Transcript
20		08/05/2020	Presentation   Transcript
21		08/12/2020	Presentation   Transcript
22		08/19/2020	Presentation   Transcript
23		08/26/2020	Presentation   Transcript
24		09/02/2020	Presentation   Transcript
25		09/09/2020	Presentation   Transcript
26		09/16/2020	Presentation   Transcript
27		09/23/2020	Presentation   Transcript
28		09/30/2020	Presentation   Transcript
29		10/07/2020	Presentation   Transcript
30		10/14/2020	Presentation   Transcript
31		10/21/2020	Presentation   Transcript
32		10/28/2020	Presentation   Transcript
33		11/04/2020	Presentation   Transcript
34		11/18/2020	Presentation   Transcript
35		12/02/2020	Presentation   Transcript
36		12/09/2020	Presentation   Transcript
37		12/16/2020	Presentation   Transcript
38		01/06/2021	Presentation   Transcript
39		01/13/2021	Presentation   Transcript
40		01/27/2021	Presentation   Transcript
41		02/03/2021	Presentation   Transcript
42		02/10/2021	Presentation   Transcript   Slides
43		02/17/2021	Presentation   Transcript
44		02/24/2021	Presentation   Transcript
45		03/03/2021	Presentation   Transcript
46		03/10/2021	Presentation   Transcript
47		03/17/2021	Presentation   Transcript
48		03/24/2021	Presentation   Transcript
49		03/31/2021	Presentation   Transcript
50		04/07/2021	Presentation   Transcript
51		04/14/2021	Presentation   Transcript
52		04/21/2021	Presentation   Transcript
53		04/28/2021	Presentation   Transcript
54		05/05/2021	Presentation   Transcript
55		05/12/2021	Presentation   Transcript
56		05/19/2021	Presentation   Transcript
57		05/26/2021	Presentation   Transcript
58		06/02/2021	Presentation   Transcript
59		06/09/2021	Presentation   Transcript
60		06/16/2021	Presentation   Transcript
61		06/23/2021	Presentation   Transcript
62		06/30/2021	Presentation   Transcript
63		07/14/2021	Presentation   Transcript
64		07/28/2021	Presentation   Transcript
65		08/04/2021	Presentation   Transcript
66		08/11/2021	Presentation   Transcript
67		08/18/2021	Presentation   Transcript
68		08/25/2021	Presentation   Transcript
69		09/08/2021	Presentation   Transcript
70		09/22/2021	Presentation   Transcript
71		10/06/2021	Presentation   Transcript
72		10/20/2021	Presentation   Transcript
73		11/17/2021	Presentation   Transcript   Slides
74		12/01/2021	Presentation   Transcript
75		12/15/2021	Presentation   Transcript
76	COVID-19	01/12/2022	Presentation   Transcript
77	COVID-19	01/26/2022	Presentation   Transcript
78	COVID-19	02/09/2022	Presentation   Transcript
79	COVID-19	02/23/2022	Presentation   Transcript
80	COVID-19	03/09/2022	Presentation   Transcript
81	COVID-19	03/23/2022	Presentation   Transcript
82	COVID-19	04/06/2022	Presentation   Transcript
83	COVID-19	04/20/2022	Presentation   Transcript
84	COVID-19	05/04/2022	Presentation   Transcript
85	COVID-19	05/18/2022	Presentation   Transcript
86	COVID-19	06/01/2022	Presentation   Transcript
87	COVID-19	06/15/2022	Presentation   Transcript
88	COVID-19	06/29/2022	Presentation   Transcript
89	COVID-19	07/27/2022	Presentation   Transcript
90	COVID-19	08/24/2022	Presentation   Transcript
91	Monkeypox	09/14/2022	Presentation   Transcript   Printable Slides
92	Monkeypox	09/21/2022	Presentation   Transcript
93	COVID-19 and Monkeypox	09/28/2022	Presentation   Transcript   Printable Slides
94	Monkeypox	10/05/2022	Presentation   Transcript
95	Monkeypox	10/12/2022	Presentation   Transcript
96	COVID-19 and Monkeypox	10/26/2022	Presentation   Transcript
97	Monkeypox	11/09/2022	Presentation   Transcript
98	Monkeypox and COVID-19	11/30/2022	Presentation   Transcript
99	Monkeypox (mpox) and COVID-19	12/14/2022	Presentation   Transcript
100	Monkeypox (mpox) and COVID-19	01/11/2023	Presentation   Transcript   Printable Slides
101	Monkeypox (mpox) and COVID-19	02/15/2023	Presentation   Transcript   Printable Slides
102	Monkeypox (mpox) and COVID-19	03/22/2023	Presentation   Transcript   Printable Slides
103	COVID-19	04/26/2023	Presentation   Transcript   Printable Slides

2021 and 2020 virtual town hall presentations and transcripts are archived and located in the Specialty Technical Topics section as: Coronavirus (COVID-19) Test Development and Validation Virtual Town Hall Series.

Unique Device Identification (UDI) System

1. Unique Device Identification (UDI) System Regulatory Overview
Presentation   Printable Slides   Transcript

2. Global Unique Device Identification Database (GUDID) Account Request: Preparation and Process
Presentation   Printable Slides   Transcript

3. The GUDID Device Identifier (DI) Record
Presentation   Printable Slides   Transcript

4. GUDID HL7 SPL Submission Option
Presentation   Printable Slides   Transcript

5. Optimizing GUDID Data Quality
Presentation   Printable Slides   Transcript

6. Unique Device Identification: Direct Marking of Devices Final Guidance
Presentation   Printable Slides   Transcript

7. Unique Device Identification: Convenience Kits, Final Guidance
Presentation   Printable Slides   Transcript

Specialty Technical Topics - (Updated 1/13/25)

COVID-19 Transition Policy

COVID-19 Transition Policy for Devices, Final Guidances
Presentation   Printable Slides   Transcript

Device-Specific Topics

Dental Devices Premarket Submissions
Presentation   Printable Slides   Transcript

Final Guidance on "General Wellness: Policy for Low-Risk Devices"
Presentation   Printable Slides   Transcript

Digital Health Software Precertification (PreCert) Pilot Program
Presentation   Printable Slides   Transcript

Hearing Aids and Personal Sound Amplification Products
Presentation   Printable Slides   Transcript

Overview of the Final Order calling for PMAs for AEDs
Presentation   Printable Slides   Transcript

Self Monitoring Blood Glucose Systems for Over-the-Counter Use & Blood Glucose Monitoring Systems for Prescription Point-of-Care Use 
Presentation   Printable Slides   Transcript

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Animal-Related Policy

Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) Final Guidance
Presentation   Printable Slides   Transcript

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Biocompatibility

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]
Presentation   Printable 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]
Presentation   Printable Slides   Transcript

Color Additives
Presentation   Printable Slides   Transcript

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Collaboration

Collaborative Communities: Addressing Healthcare Challenges Together
Presentation   Printable Slides   Transcript

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Custom Devices

Custom Device Exemption
Presentation   Printable Slides   Transcript

Technical Considerations for Additive Manufactured Medical Devices
Presentation   Printable Slides   Transcript

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Digital Health

Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act: Final Guidance
Presentation   Printable Slides   Transcript

Clinical Decision Support Software, Final Guidance 
Presentation   Printable Slides   Transcript

Content of Premarket Submissions for Device Software Functions, Final Guidance
Presentation   Printable Slides   Transcript

Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - Final Guidance
Presentation   Printable Slides   Transcript

Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices Final Guidance
Presentation   Printable Slides   Transcript

Digital Health
Presentation   Printable Slides   Transcript

Digital Health Center of Excellence Listening Session #1
Presentation   Printable Slides   Transcript

Digital Health Center of Excellence Listening Session #2 
Presentation   Printable Slides   Transcript

Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions, Final Guidance (New Module 1/13/2025)
Printable Slides

Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions 
Presentation   Printable Slides   Transcript

Postmarket Management of Cybersecurity in Medical Devices Final Guidance 
Presentation   Printable Slides   Transcript

Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act, Draft Guidance (New Module 5/9/2024)
Presentation   Printable Slides   Transcript

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Human Factors

Applying Human Factors and Usability Engineering to Medical Devices
Presentation   Printable Slides   Transcript

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Home Use

FDA's Home Use Medical Device Initiative
Presentation   Printable Slides

Promoting Patient Safety with Home Use Devices
Presentation   Printable Slides

Home Use Medical Devices: New Risks
Presentation   Printable Slides

Medical Devices in the Home: Design Considerations and Guidance for Industry
Presentation   Printable Slides   Transcript

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Medical Device Development Tools

Qualification of Medical Device Development Tools: Final Guidance
Presentation   Printable Slides   Transcript

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Medical Imaging

Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment 
Presentation   Printable Slides   Transcript

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Neurological Devices

Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder: Draft Guidance
Presentation   Printable Slides   Transcript

Regulatory Advice for Investigators and Sponsors of Neurological Devices and the Path to Initiating Human Studies
Presentation   Printable Slides   Transcript

Regulatory Overview for Developers and Sponsors of Neurological Devices: An Introduction to Premarket Approvals 
Presentation   Printable Slides   Transcript

Regulatory Overview for Developers and Sponsors of Neurological and Physical Medicine Devices: An Introduction to the De Novo Pathway
Presentation   Printable Slides   Transcript

Regulatory Overview for Developers and Sponsors of Neurological Devices: An Introduction to Humanitarian Device Exemptions (HDEs) 
Presentation   Printable Slides   Transcript

FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder
Presentation   Printable Slides   Transcript

Implanted BCI Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations Final Guidance
Presentation   Printable Slides   Transcript

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Patient Engagement

Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use In Medical Device Evaluation, Final Guidance
Presentation   Printable Slides   Transcript

Patient Engagement in the Design and Conduct of Medical Device Clinical Studies, Final Guidance
Presentation   Printable Slides   Transcript

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Personal Protective Equipment (PPE)

Enforcement Policy for Personal Protective Equipment (PPE) During COVID-19: Immediately in Effect Guidance - April 6, 2020
Presentation   Printable Slides   Transcript

Respirators for Health Care Personnel Use during COVID-19 Pandemic - June 9, 2020
Presentation   Printable Slides   Transcript

Respirators for Health Care Personnel Use during COVID-19 Pandemic - June 23, 2020
Presentation   Printable Slides   Transcript 

Respirators for Health Care Personnel Use during COVID-19 Pandemic - July 7, 2020
Presentation   Printable Slides   Transcript

Respirators for Health Care Personnel Use during COVID-19 Pandemic - July 21, 2020
Presentation   Transcript

Regulation of Face Masks and Surgical Masks During the COVID-19 Pandemic - August 4, 2020
Presentation   Transcript

FDA's Surgical Masks Umbrella EUA - August 18, 2020
Presentation   Transcript

CDC/NIOSH's Surgical N95 Respirator Guidance - September 1, 2020
Presentation   Printable Slides   Transcript

Gowns and Other Apparel for Use by Health Care Personnel in COVID-19 Pandemic
Presentation   Printable Slides   Transcript

Respirators and Other PPE for Health Care Personnel Use 
Presentation   Transcript

Protective Barrier Enclosure Emergency Use Authorizations (EUAs)
Presentation   Printable Slides   Transcript

Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic
Presentation   Printable Slides   Transcript

Gowns - Regulatory Responsibilities
Presentation   Printable Slides   Transcript

Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic
Presentation   Printable Slides   Transcfript

Enforcement Policy for Bioburden Reduction Systems Using Dry Heat to Support Single-User Reuse of Certain Filtering Facepiece Respirators during the COVID-19 Pandemic
Presentation   Printable Slides   Transcript

Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic
Presentation   Printable Slides   Transcript

Transitioning from the Use of Decontaminated Disposable Respirators
Presentation   Printable Slides   Transcript

Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic
Printable Slides

Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic 
Presentation   Printable Slides   Transcript

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Regulatory Science Tools

Targeted Box and Blocks Test (tBBT)
Presentation   Transcript

Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions, Final Guidance
Presentation   Printable Slides   Transcript

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Reprocessing

Webinar - Duodenoscope Sampling and Culturing
Presentation   Printable Slides   Transcript

Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
Presentation   Printable Slides   Transcript

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Sterility

FDA Innovation Challenges: Identify Sterilization Alternatives and Reduce Ethylene Oxide Emissions
Printable Slides   Transcript

Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile Final Guidance
Presentation   Printable Slides   Transcript

Medical Device Sterilization Town Hall Series (Updated 12/20/24)

Series Number	Topic	Date	Materials
01	Medical Device Sterilization Town Hall Overview	01/10/2024	Presentation Transcript Slides
02	FDA’s Sterilization Related Activities	01/26/2024	Presentation Transcript Slides
03	Premarket Pt 1: New submissions & considerations	02/07/2024	Presentation Transcript Slides
04	Premarket Pt 2: Modifications and Master Files	02/29/2024	Presentation Transcript Slides
05	Premarket Pt 3: Use of Standards & Standards Development	03/21/2024	Presentation Transcript Slides
06	Topics and Formats for the Continuing Town Hall Series	04/29/2024	Presentation Transcript Slides
07	Sterilization Method Selection	05/23/2024	Presentation Transcript Slides
08	Sterilization Open Q&A	06/12/2024	Presentation Transcript Slides
09	Mock Pre-Submission for Sterilization Method Change	07/10/2024	Presentation Transcript Slides
10	Bioburden, bacterial endotoxin and packaging integrity testing for sterile medical devices	08/07/2024	Presentation Transcript Slides
11	Effective use of Sterility Master Files	09/11/2024	Presentation Transcript Slides
12	Predetermined Change Control Plans (PCCPs)	10/09/2024	Presentation Transcript Slides
13	Supporting medical device innovators and bundling sterility submissions	10/30/2024	Presentation Transcript Slides
14	Recognized consensus standards and biocompatibility assessment considerations	11/20/2024	Presentation Transcript Slides
15	New transitional enforcement policy, VH2O2 diffusion research/modeling, series updates, wrap up and next steps	12/04/2024	Presentation Transcript Slides

Radiation-Emitting Products

How to Get Your Electronic Product on the U.S. Market
Presentation   Printable Slides   Transcript

Electronic Product Certification and Quality Testing Programs
Presentation   Printable Slides   Transcript

Marketing Clearance of Diagnostic Ultrasound Systems and Transducers: Final Guidance
Presentation   Printable Slides   Transcript

Pediatric Information for X-ray Imaging Device Premarket Notifications
Presentation   Printable Slides   Transcript

Phantom Image Scoring (For MQSA Inspectors)
Presentation

eSubmitter Tutorial Presentations
eSubmitter Tutorial Presentations   Radiological Health Report Tutorial

510(k) Third Party Review Program (for Third Party Review Organizations)

510(k) Third Party Review Program: Overview 
Presentation   Transcript

X-Ray Systems
Presentation   Printable Slides   Transcript

510(k) Third Party Review Program: Final Guidance510(k) Third Party Review Program: Final Guidance
Presentation   Printable Slides   Transcript

Overview of the 510(k) Process: Guide for Third Party Reviewers
Presentation   Printable Slides   Transcript

Deficiency Writing for Third Party Reviewers
Presentation   Printable Slides   Transcript

Deficiency Writing for Third Party Reviewers: Examples
Presentation   Printable Slides   Transcript

Industry Basics Workshop Series

November 2022 Industry Basics Workshop: Understanding Risk Management with Medical Devices 
Full Presentation   Workshop Page

April 2021 Industry Basics Workshop: Consensus Standards and the Accreditation Scheme for Conformity Assessment (ASCA) Pilot
Full Presentation   Workshop Page

November 2019 Industry Basics Workshop: 513(g) Requests for Information and Custom Device Exemption
Full Presentation   Workshop Page

November 2018 Industry Basics Workshop: Production and Process Controls; and Documents, Change Control, and Records
Full Presentation   Workshop Page

November 2017 Industry Basics Workshop: Quality System - Nonconforming Product and Complaint Files
Full Presentation   Workshop Page   Transcript

November 2016 Industry Basics Workshop: Quality System - Management Controls and Design Controls 
Full Presentation   Workshop Page
To view specific chapters of the video presentation, select the circular "Chapters" icon in the lower left-hand corner of the window. Click on the desired chapter and press play. To close chapter view, click the X in the upper right-hand corner.

March 2016 Industry Basics Workshop: Unique Device Identification (UDI) Part II, Submitting Information to GUDID 
Full Presentation   Workshop Page

January 2016 Industry Basics Workshop: Unique Device Identification (UDI) Part I
Full Presentation   Workshop Page

November 2015 Industry Basics Workshop: Purchasing Controls and Process Validation
Full Presentation   Workshop Page with Presentation in Segments

November 2014 Industry Basics Workshop: IDE, 510(k), de novo, CAPA, eMDR
Full Presentation   Workshop Page with Presentation in Segments  

 

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Resources

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.

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

DICE@fda.hhs.gov

(800) 638-2041

(301) 796-7100

Office of Communication, Information Disclosure, Training and Education