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Regulatory Education for Industry (REdI) Annual Conference
June 6-10 – Register for this conference on topics including 510(k)s, inspections, and regulatory responsibilities.

CDER Small Business and Industry Assistance (SBIA) Regulatory Education for Industry (REdI) Annual Conference 2022, June 6-10

 

 

 

Welcome to CDRH Learn, the FDA Center for Devices and Radiological Health’s (CDRH) web page for multimedia industry education. CDRH Learn is our innovative educational tool, which consists of learning modules describing many aspects of medical device and radiation emitting product regulations, covering both premarket and postmarket topics. This tool is intended to provide industry with information that is comprehensive, interactive, and easily accessible. Modules are provided in various formats, including videos, audio recordings, and slide presentations. CDRH will determine the most appropriate format for the particular topic being presented and will post the learning module on this site to help meet your educational needs.

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Resources For You

MDUFA Small Business Program, Registration and Listing

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

How is CDRH Structured? (Updated module - 5/13/22)
Presentation   Printable Slides   Transcript

Is My Product a Medical Device?
Presentation   Printable Slides   Transcript

Medical Device User Fee Amendments of 2017 (MDUFA IV): An Introduction
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

Regulatory Overview of Device Establishment Registration and Listing
Presentation   Printable Slides

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

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

Special 510(k) Program Pilot
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

Quality in 510(k) Review Program Pilot 
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

510(k) Format Guidance, Including Standards Form, and Extensions/Clinical Trial Form and 510(k)
Presentation   Printable Slides


De Novo

De Novo Final Rule: Overview and Guidance Updates (New Module 12/23/2021)
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
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

Postmarket Surveillance under 522 Section of the Food, Drugs and Cosmetic (FD&C) Act
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 (New module - 4/21/21)
Presentation   Printable Slides   Transcript

Module 5: The ASCA Pilot: Streamlining Conformity Assessment in Device Submissions (New module - 4/21/21)
Presentation   Printable Slides   Transcript

Webinar - ASCA Pilot: Streamlining Conformity Assessment in Device Submissions (New module - 5/20/21)
Presentation   Printable Slides   Transcript
TAKE OUR SURVEY - Tell us what you think about the webinar

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

Safer Technologies Program: Draft Guidance  (New module - 2/1/21)
Printable Slides
TAKE OUR SURVEY - Tell us what you think about the webinar

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

How to Create and Submit an eCopy
Presentation

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

CDRH Final Guidance: Qualification of Medical Device Development Tools
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 2 - Computerized Systems Used in Medical Device Clinical Investigations
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 3c - Institutional Review Board: Compassionate and Emergency Use
Presentation   Printable Slides

BIMO Part 4a - Preparing for an FDA Medical Device Sponsor Inspection
Presentation   Printable Slides

BIMO Part 4b - Preparing for an FDA Clinical Investigator Inspection
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

Preparing for a Clinical Investigator Inspection
Presentation   Transcript

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

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


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 (New module 3/24/21)
Printable Slides   Transcript

(1B) Overview of the MDSAP Audit Process (New module 3/24/21)
Printable Slides   Transcript

(2) MDSAP: Management Process (New module 3/31/21)
Printable Slides   Transcript

(3) MDSAP: Device Marketing Authorization and Facility Registration (New module 3/31/21)
Printable Slides   Transcript

(4) MDSAP: Measurement, Analysis and Improvement Process (New module 4/6/21)
Printable Slides   Transcript

(5) MDSAP: Medical Device Adverse Events and Advisory Notices Reporting Process (New module 4/6/21)
Printable Slides   Transcript

(6) MDSAP: Design and Development Process (New module 4/8/21)
Printable Slides   Transcript

(7) MDSAP: Production and Service Controls Process, Part 1 (New module 4/9/21)
Printable Slides   Transcript

(8) MDSAP: Production and Service Controls Process: Part 2 (New module 4/13/21)
Printable Slides   Transcript

(9) MDSAP: Production and Service Controls Process: Part 3 (New module 4/15/21)
Printable Slides   Transcript

(10) MDSAP: Purchasing Process (New Module 9/22/2021)
Printable Slides Transcript

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

COVID-19 Transition Policy for Devices, Draft Guidances  (New module 2/22/22)
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"

Please note that the 21st Century Cures Act (12/13/2016) clarified FDA's regulation of medical software. The new law amended the definition of "device" in the Food, Drug and Cosmetic Act to exclude certain software functions, including some of those in this presentation.

The FDA is currently developing draft guidance for public comment to help industry and FDA staff understand how the 21st Century Cures Act affects FDA's oversight of medical device software. If you have questions about how the 21st Century Cures Act affects your products, or if you have comments on how the FDA should regulate medical software, please email [email protected].

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

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"
Presentation   Printable Slides   Transcript

Color Additives
Presentation   Printable Slides   Transcript


Collaboration

Collaborative Communities: Addressing Healthcare Challenges Together
Presentation   Printable Slides   Transcript


Coronavirus (COVID-19) Test Development and Validation Virtual Town Hall Series 

Series Number 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 01/12/2022 Presentation   Transcript
77 01/26/2022 Presentation   Transcript
78 02/09/2022 Presentation   Transcript
79 02/23/2022 Presentation   Transcript
80 03/09/2022 Presentation   Transcript
81 03/23/2022 Presentation   Transcript
82 04/06/2022 Presentation   Transcript
83 04/20/2022 Presentation   Transcript
84 05/04/2022 Presentation   Transcript
85 05/18/2022 Presentation   Transcript
86 06/01/2022 Presentation   Transcript

Custom Devices

Custom Device Exemption
Presentation   Printable Slides   Transcript

Technical Considerations for Additive Manufactured Medical Devices
Presentation   Printable Slides   Transcript


Digital Health

Please note that the 21st Century Cures Act (12/13/2016) clarified FDA's regulation of medical software. The new law amended the definition of "device" in the Food, Drug and Cosmetic Act to exclude certain software functions, including some of those in this presentation.

The FDA is currently developing draft guidance for public comment to help industry and FDA staff understand how the 21st Century Cures Act affects FDA's oversight of medical device software. If you have questions about how the 21st Century Cures Act affects your products, or if you have comments on how the FDA should regulate medical software, please email [email protected].

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

Digital Health Software Precertification (Pre-Cert) Pilot Program
Presentation   Printable Slides   Transcript

Digital Health
Presentation   Printable Slides   Transcript

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

Clinical Decision Support Software: Draft Guidance
Presentation   Printable Slides   Transcript

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

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
Presentation   Printable Slides   Transcript

Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - Draft Guidance
Prinatable Slides

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

PreCertification (Pre-Cert) Pilot Update
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


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


In Vitro Diagnostics

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

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

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

Clinical Laboratory Improvement Amendments (CLIA)
Presentation   Printable Slides   Transcript

CLIA Waiver Applications Draft Guidances
Presentation   Printable Slides   Transcript

3D Printed Swabs
Presentation   Printable Slides   Transcript

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


Medical Imaging

Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (New module 6/24/21)
Presentation   Printable Slides   Transcript


Neurological Devices

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
Printable Slides
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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 (New module 3/1/22)
Presentation   Printable Slides   Transcript

Patient Engagement in the Design and Conduct of Medical Device Clinical Studies, Final Guidance (Updated module 4/1/22)
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   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
Presentation   Printable Slides   Transcript
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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 (New module 4/26/21)
Presentation   Printable Slides   Transcript

Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic (New module 6/8/21)
Printable Slides

Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic (New module 7/13/2021)
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


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

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

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  

Contact Us

Division of Industry and Consumer Education (DICE)
Office of Communication and Education
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

1-800-638-2041
301-796-7100
[email protected]



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