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        Training and Continuing Education

CDRH Learn

                        
                CDRH Learn Course List (Spanish) Home
          Training and Continuing Education
          CDRH LearnTraining and Continuing Education CDRH Learn
  	
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    PrintWelcome 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**
Modules should be compatible with most devices (computers, tablets, smart phones). We recommend you use Mozilla Firefox or Google Chrome to view modules. If you encounter a viewing error, we suggest you try another browser.


Start Here/The Basics! (Updated Module 10/16/2023)
*MDUFA Small Business Program, Registration and Listing*

An Introduction to FDA's Regulation of Medical DevicesPresentation   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 StatesPresentation   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) WebsitePresentation   Printable Slides

FURLS Device Registration and Listing Module for Annual RegistrationPresentation

FURLS Device Registration and Listing Module for Initial RegistrationPresentation

How to Study and Market Your Device -*(Updated 11/20/23)*
*510k, De Novo, IDE, PMA, HUD/HDE, Q-Submissions, Standards, Classification*

**Premarket Notification (510k)**

The 510(k) ProgramPresentation   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 GuidancePresentation   Printable Slides   Transcript

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

Safety and Performance Based Pathway Performance CriteriaPresentation   Printable Slides   Transcript

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

De Novo ProgramPresentation   Printable Slides   Transcript

**Clinical Studies/Investigational Device Exemption (IDE)**

IDE BasicsPresentation   Printable Slides   Transcript

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

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

An Update on the FDA's Medical Device Clinical Trials ProgramPresentation    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 EnterprisePresentation   Printable Slides   Transcript

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

FDA Guidance: Design Considerations for Pivotal Clinical Investigations for Medical DevicesPresentation   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 StudiesPresentation   Printable Slides   Transcript

FDA Decisions for Investigational Device Exemption (IDE) Clinical InvestigationsPresentation   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 GuidancesPresentation   Printable Slides   Transcript

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

**Premarket Approval Application (PMA)**

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

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

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

Module 1: Office of Orphan Products DevelopmentPresentation   Printable Slides   Transcript

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

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

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

Humanitarian Device Exemption ProgramPresentation   Printable Slides   Transcript

**Q-Submissions**

Q-Submission Program for Medical Device SubmissionsPresentation   Printable Slides   Transcript

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

**Standards**

Module 1: Standards OverviewPresentation   Printable Slides   Transcript

Module 2: Standards Resources and Premarket UsePresentation   Printable Slides   Transcript

Module 3: CDRH Standards Recognition ProcessPresentation   Printable Slides   Transcript

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

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

Appropriate Use of Voluntary Consensus StandardsPresentation   Printable Slides   Transcript

Recognition and Withdrawal of Voluntary Consensus Standards - Final GuidancePresentation   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 GuidancePrintable 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 DevicesPresentation   Printable Slides   Transcript

Patient Preference Information Presentation   Printable Slides   Transcript

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

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

The Least Burdensome Provisions: Concept and Principles Final GuidancePresentation******Printable Slides   Transcript

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

Multiple Function Device Products: Policy and ConsiderationsPresentation   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 InformationPresentation   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 ProgramPresentation   Printable Slides

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

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

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

Postmarket Activities
*Quality System, Exporting, Device Recalls, MDR, Inspection - Global Harmonization*

**Overview of the Quality System**

**Start Here!** Overview of the Quality SystemPresentation   Printable Slides   Transcript

Production and Process ControlsPresentation   Printable Slides   Transcript

Production and Process Controls, Part 2Presentation   Printable Slides   Transcript

Documents, Change Control, and RecordsPresentation   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 ControlsPresentation   Printable Slides   Transcript

Process ValidationPresentation   Printable Slides   Transcript

Corrective and Preventive ActionsPresentation   Printable Slides   Transcript

Nonconforming ProductPresentation   Printable Slides   Transcript

Complaint FilesPresentation   Printable Slides   Transcript

**Exports and Imports**

Exporting Medical DevicesPresentation   Printable Slides   Transcript

Importing Medical Devices Into the United StatesPresentation   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 EmergencyPresentation   Printable Slides   Transcript

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

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

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

**Medical Device Recalls**

Distinguishing Medical Device Recalls from Medical Device EnhancementsPresentation   Printable Slides   Transcript

Introduction to Medical Device Recalls: Industry ResponsibilitiesPresentation   Printable Slides

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

Electronic Submission of 806 Reports of Corrections and RemovalsPrintable Slides

Recall Communication: Medical Device Model Press ReleasePresentation   Printable Slides   Transcript

Recall Communication: Medical Device Model Recall Notification LetterPresentation   Printable Slides   Transcript

Medical Device Recalls: Guidance for IndustryPresentation

**Medical Device Reporting (MDR)**

Overview of Medical Device ReportingPresentation   Printable Slides   Transcript

Medical Device Reporting for Mandatory ReportersPresentation   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 TutorialPresentation   Transcript

**Inspections - Global Harmonization**

(1A) Introduction to the MDSAP ProgramPrintable Slides   Transcript

(1B) Overview of the MDSAP Audit ProcessPrintable Slides   Transcript

(2) MDSAP: Management ProcessPrintable Slides   Transcript

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

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

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

(6) MDSAP: Design and Development ProcessPrintable Slides   Transcript

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

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

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

(10) MDSAP: Purchasing Process Printable Slides Transcript

In Vitro Diagnostics - *(Updated 12/19/23)*
*IVD Development, CLIA, and Virtual Town Hall Series*

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

3D Printed SwabsPresentation   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 GuidancesPresentation   Printable Slides   Transcript

Clinical Laboratory Improvement Amendments (CLIA)Presentation   Printable Slides   Transcript

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

Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test DevicesPresentation   Printable Slides   Transcript

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

Final Guidances on Next Generation Sequencing-based TestsPresentation   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 ProductPresentation   Printable Slides   Transcript

Virtual Town Hall Series

Series
			Number
			Topic
			Date
			Materials0
			
			03/02/2020
			Presentation   Transcript   Slides00
			
			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 OverviewPresentation   Printable Slides   Transcript

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

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

4. GUDID HL7 SPL Submission OptionPresentation   Printable Slides   Transcript

5. Optimizing GUDID Data QualityPresentation   Printable Slides   Transcript

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

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

Specialty Technical Topics - *(New module 1/26/24)*

**COVID-19 Transition Policy**

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

**Device-Specific Topics**

Dental Devices Premarket SubmissionsPresentation   Printable Slides   Transcript

Final Guidance on "General Wellness: Policy for Low-Risk Devices"

Presentation   Printable Slides   Transcript

Digital Health Software Precertification (PreCert) Pilot ProgramPresentation   Printable Slides   Transcript

Hearing Aids and Personal Sound Amplification ProductsPresentation   Printable Slides   Transcript

Overview of the Final Order calling for PMAs for AEDsPresentation   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 GuidancePresentation   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 AdditivesPresentation   Printable Slides   Transcript

**Collaboration**

Collaborative Communities: Addressing Healthcare Challenges TogetherPresentation   Printable Slides   Transcript

**Custom Devices**

Custom Device ExemptionPresentation   Printable Slides   Transcript

Technical Considerations for Additive Manufactured Medical DevicesPresentation   Printable Slides   Transcript

**Digital Health**

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

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

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

Digital HealthPresentation   Printable Slides   Transcript

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

Clinical Decision Support Software, Final Guidance Presentation   Printable Slides   Transcript

Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act: Final GuidancePresentation   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

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

PreCertification (Pre-Cert) Pilot UpdatePresentation   Printable Slides   Transcript

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

**Home Use**

FDA's Home Use Medical Device InitiativePresentation   Printable Slides

Promoting Patient Safety with Home Use DevicesPresentation   Printable Slides

Home Use Medical Devices: New RisksPresentation   Printable Slides

Medical Devices in the Home: Design Considerations and Guidance for IndustryPresentation   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 StudiesPresentation   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 PathwayPresentation   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 DisorderPresentation   Printable Slides   Transcript

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

**Patient Engagement**

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

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

**Personal Protective Equipment (PPE)**

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

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

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

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

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

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

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

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

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

Gowns - Regulatory ResponsibilitiesPresentation   Printable Slides   Transcript

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

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

Transitioning from the Use of Decontaminated Disposable RespiratorsPresentation   Printable Slides   Transcript

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

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

**Sterility**

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

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

Medical Device Sterilization Town Hall Series ***(Updated 1/26/24)***

Series
			Number
			Topic
			Date
			Materials01
			Medical Device Sterilization Town Hall Overview
			01/10/2024
			Presentation   Transcript   Slides**02**
			FDA’s Sterilization Related Activities
			01/26/2024
			Slides

Radiation-Emitting Products

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

Electronic Product Certification and Quality Testing ProgramsPresentation   Printable Slides   Transcript

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

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

Phantom Image Scoring (For MQSA Inspectors)Presentation

eSubmitter Tutorial PresentationseSubmitter 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 SystemsPresentation   Printable Slides   Transcript

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

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

Deficiency Writing for Third Party ReviewersPresentation   Printable Slides   Transcript

Deficiency Writing for Third Party Reviewers: ExamplesPresentation   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 PageTo 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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            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.
          
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                                                                                  Content current as of:
      01/26/2024
                  
                   
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