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Small Business and Industry Assistance - 2024 Regulatory Education for Industry - Hybrid May 29-30

 

 

 

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. 

Tips for Viewing Modules
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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 (New 7/19/23)
Presentation  Printable Slides  Transcript


MDUFA Small Business Program

Suggested tip before you watch this module:  Gather the materials you'll need to prepare Form FDA 3602 or Form FDA 3602A.  They are identified under the Device Advice section: "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


Registration and Listing (Updated 10/16/23)

Device Registration and Listing: An Introduction – Part 1 (Updated 10/16/23)
Presentation   Printable Slides   Transcript

Device Registration and Listing: An Introduction – Part 2 (Updated 10/16/23)
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
Presentation

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 (Updated 11/3/23)

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


De Novo

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

De Novo Program
Presentation   Printable Slides   Transcript


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] (Updated 11/20/2023)
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

Final Guidance on "Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies"
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


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


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


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


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


Cross-Cutting Premarket Policy

CDRH Portal Overview and Feature Walkthrough (New 9/29/23)
Presentation   Printable Slides   Transcript

Safer Technologies Program: Draft Guidance
Printable Slides

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

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

Patient Preference Information 
Presentation   Printable Slides   Transcript

Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices
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

The Least Burdensome Provisions: Concept and Principles Final Guidance
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

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


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


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

Quality System, 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


Exports and Imports

Exporting Medical Devices
Presentation   Printable Slides   Transcript

Importing Medical Devices Into the United States
Presentation   Printable Slides   Transcript


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   Transcripts

Remanufacturing of Medical Devices Draft Guidance and Strengthening Cybersecurity Practices Associated with Servicing of Medical Devices Discussion Paper
Printable Slides

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


Medical Device Recalls

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

Introduction to Medical Device Recalls: Industry Responsibilities
Presentation   Printable Slides

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

Recall Communication: Medical Device Model Press Release
Presentation   Printable Slides   Transcript

Recall Communication: Medical Device Model Recall Notification Letter
Presentation   Printable Slides   Transcript

Medical Device Recalls: Guidance for Industry
Presentation


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


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

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 (Updated 12/18/23)
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

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

Laboratory Developed Tests; Medical Devices: Proposed Rule (Updated 11/3/23)
Presentation   Printable Slides   Transcript

Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program (Updated 12/19/23)
Presentation   Printable Slides   Transcript

Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product
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.

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

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


Animal-Related Policy

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


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] - (Updated 10/24/23)
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


Collaboration

Collaborative Communities: Addressing Healthcare Challenges Together
Presentation   Printable Slides   Transcript


Custom Devices

Custom Device Exemption
Presentation   Printable Slides   Transcript

Technical Considerations for Additive Manufactured Medical Devices
Presentation   Printable Slides   Transcript


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 (Updated 11/17/2023)
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/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


Human Factors

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


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


Medical Imaging

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


Neurological Devices

Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder: Draft Guidance (Updated 9/19/23)
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


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


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


Regulatory Science Tools

Qualification of Medical Device Development Tools: Final Guidance (Updated 9/19/23)
Presentation   Printable Slides   Transcript

Targeted Box and Blocks Test (tBBT)
Presentation   Transcript

Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions, Final Guidance (Updated 1/22/24)
Presentation   Printable Slides   Transcript


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


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 6/20/24)

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

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: 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

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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Contact Point
Division of Industry and Consumer Education
Center for Devices and Radiological Health
Food and Drug Administration
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(800) 638-2041
(301) 796-7100

Hours Available

Office of Communication and Education


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