CDRH Learn
Welcome to CDRH Learn! CDRH Learn is our multi-media educational resource, featuring learning modules that address medical device and radiation emitting product laws, regulations, guidances, and policies, across the entire product life cycle. These modules provide industry with information that is comprehensive, interactive, and easily accessible. Modules are provided in various formats, including videos, audio recordings, and slide presentations.
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An Introduction to FDA's Regulation of Medical Devices
Presentation Printable Slides Transcript
How is CDRH Structured?
Presentation Printable Slides Transcript
Is My Product a Medical Device?
Presentation Printable Slides Transcript
An Introduction to the Medical Device User Fee Program: MDUFA V
Presentation Printable Slides Transcript
MDUFA Small Business Program
For information about submissions to the Small Business Determination (SBD) program, please reference "How to submit a Small Business Certification Request".
How to Complete Form FDA 3602: MDUFA Small Business Qualification and Certification for a Business Headquartered in the United States.
How to Complete Form FDA 3602A: MDUFA Foreign Small Business Certification Request for a Business Headquartered Outside the United States.
Registration and Listing
Device Registration and Listing: An Introduction – Part 1
Presentation Printable Slides Transcript
Device Registration and Listing: An Introduction – Part 2
Presentation Printable Slides Transcript
Paying the Annual Registration User Fee via the Device Facility User Fee (DFUF) Website
Presentation Printable Slides
FURLS Device Registration and Listing Module for Annual Registration
Presentation
FURLS Device Registration and Listing Module for Initial Registration
Presentatio
How to Study and Market Your Device - (New module 10/18/24)
510k, De Novo, IDE, PMA, HUD/HDE, Q-Submissions, Standards, Classification
Premarket Notification (510k)
The 510(k) Program
Presentation Printable Slides Transcript
CDRH's New Draft Guidances to Continue to Modernize the 510(k) Program
Presentation Printable Slides Transcript
The Special 510(k) Program: Final Guidance
Presentation Printable Slides Transcript
Safety and Performance Based Pathway Criteria for Certain Device Types Final Guidances
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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]
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
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Final Guidance on "Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies"
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Evaluation of Sex-Specific Data in Medical Device Clinical Studies
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FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations
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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
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Module 5: The ASCA Pilot: Streamlining Conformity Assessment in Device Submissions
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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
Presentation Printable Slides Transcript
Combination Product Updates for "Acceptance and Filing Reviews for Premarket Approval Applications" and "Refuse to Accept Policy for 510(k)s"
Presentation Printable Slides Transcript
Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions
Presentation Printable Slides Transcript
Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications
Presentation Printable Slides Transcript
Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle, Draft Guidance (Updated 10/18/2024)
Presentation Printable Slides Transcript
The Least Burdensome Provisions: Concept and Principles Final Guidance
Presentation Printable Slides Transcript
Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices
Presentation Printable Slides Transcript
Multiple Function Device Products: Policy and Considerations
Presentation Printable Slides Transcript
Patient Preference Information
Presentation Printable Slides Transcript
Predetermined Change Control Plans for Medical Devices, Draft Guidance (Updated 9/11/24)
Presentation Printable Slides Transcript
Safer Technologies Program: Draft Guidance
Printable Slides
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
Presentation Printable Slides Transcript
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
Postmarket Activities (Updated module 10/16/24)
Quality System, QMSR, Exporting, Device Recalls, MDR, Inspection - Global Harmonization
Overview of the Quality System
Start Here! Overview of the Quality System
Presentation Printable Slides Transcript
Production and Process Controls
Presentation Printable Slides Transcript
Production and Process Controls, Part 2
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Documents, Change Control, and Records
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Design Controls
Presentation Printable Slides Transcript
Risk Basics for Medical Devices
Presentation Printable Slides Transcript
Application of Risk Management Principles for Medical Devices
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Management Controls
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Purchasing Controls
Presentation Printable Slides Transcript
Process Validation
Presentation Printable Slides Transcript
Corrective and Preventive Actions
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Nonconforming Product
Presentation Printable Slides Transcript
Complaint Files
Presentation Printable Slides Transcript
Quality Management System Regulation (New section)
Overview of Quality Management System Regulation (New 8/30/24)
Presentation Printable Slides Transcript
Navigating the Quality Management System Regulation (New 8/30/24)
Presentation Printable Slides Transcript
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 Transcript
Remanufacturing of Medical Devices, Final Guidance (Updated 9/17/24)
Presentation Printable Slides Transcript
Computer Software Assurance for Production and Quality System Software, Draft Guidance
Presentation Printable Slides Transcript
Voluntary Improvement Program (Updated 10/16/24)
Presentation Printable Slides Transcript
Medical Device Recalls
Introduction to Medical Device Recalls
Presentation Printable Slides Transcript
Distinguishing Medical Device Recalls from Medical Device Enhancements
Presentation Printable Slides Transcript
Recall Module 21 CFR Part 806: Medical Devices; Reports of Corrections and Removals
Presentation Printable Slides
Electronic Submission of 806 Reports of Corrections and Removals
Printable Slides
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)
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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
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(1B) Overview of the MDSAP Audit Process
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(2) MDSAP: Management Process
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(3) MDSAP: Device Marketing Authorization and Facility Registration
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(4) MDSAP: Measurement, Analysis and Improvement Process
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(5) MDSAP: Medical Device Adverse Events and Advisory Notices Reporting Process
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(6) MDSAP: Design and Development Process
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(7) MDSAP: Production and Service Controls Process, Part 1
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(8) MDSAP: Production and Service Controls Process: Part 2
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(9) MDSAP: Production and Service Controls Process: Part 3
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(10) MDSAP: Purchasing Process
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In Vitro Diagnostics - (Updated 12/06/24)
IVD Development, CLIA, and Virtual Town Hall Series
3D Printed Swabs
Presentation Printable Slides Transcript
Antimicrobial Susceptibility Test System Devices - Updating Breakpoints in Device Labeling
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CLIA Waiver Applications Draft Guidances
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Clinical Laboratory Improvement Amendments (CLIA)
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Clinical Laboratory Improvement Amendments (CLIA) Waiver Applications Final Guidances
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Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices
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Electromagnetic Compatibility (EMC) of In Vitro Diagnostic Devices
Presentation Printable Slides Transcript
Enforcement Policies for Certain In Vitro Diagnostic Devices - Draft Guidances (Updated 6/11/2024)
Presentation Printable Slides Transcript
Final Guidances on Next Generation Sequencing-based Tests
Presentation Printable Slides Transcript
In Vitro Diagnostic Product (IVD): Classification (Updated 8/18/2024)
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In Vitro Diagnostic Products (IVDs) - MDR Requirements, Correction and Removal Reporting Requirements, and Quality System Complaint Requirements (Updated 8/27/2024)
Presentation Printable Slides Transcript
Labeling Requirements for In Vitro Diagnostic Products (IVD), Including LDTs, Under 21 CFR 809.10(b) (Updated 9/27/2024)
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Laboratory Developed Tests; Medical Devices: Final Rule (Updated 5/20/24)
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Laboratory Developed Tests; Medical Devices: Proposed Rule
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Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program
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Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product
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Registration & Listing Requirements for In Vitro Diagnostic Products (IVDs), Including Laboratory Developed Tests (LDTs) (Updated 12/06/2024)
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Total Product Life Cycle Approach to In Vitro Diagnostic Products (IVDs) (Updated 10/29/2024)
Presentation Printable Slides Transcript
Virtual Town Hall Series
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]
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
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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
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Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices Final Guidance
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Digital Health
Presentation Printable Slides Transcript
Digital Health Center of Excellence Listening Session #1
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Digital Health Center of Excellence Listening Session #2
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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 Device Development Tools
Qualification of Medical Device Development Tools: Final Guidance
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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
Presentation Printable Slides Transcript
Regulatory Advice for Investigators and Sponsors of Neurological Devices and the Path to Initiating Human Studies
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Regulatory Overview for Developers and Sponsors of Neurological Devices: An Introduction to Premarket Approvals
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Regulatory Overview for Developers and Sponsors of Neurological and Physical Medicine Devices: An Introduction to the De Novo Pathway
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Regulatory Overview for Developers and Sponsors of Neurological Devices: An Introduction to Humanitarian Device Exemptions (HDEs)
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FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder
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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
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Patient Engagement in the Design and Conduct of Medical Device Clinical Studies, Final Guidance
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Personal Protective Equipment (PPE)
Enforcement Policy for Personal Protective Equipment (PPE) During COVID-19: Immediately in Effect Guidance - April 6, 2020
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Respirators for Health Care Personnel Use during COVID-19 Pandemic - June 9, 2020
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Respirators for Health Care Personnel Use during COVID-19 Pandemic - June 23, 2020
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Respirators for Health Care Personnel Use during COVID-19 Pandemic - July 7, 2020
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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
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Gowns and Other Apparel for Use by Health Care Personnel in COVID-19 Pandemic
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Respirators and Other PPE for Health Care Personnel Use
Presentation Transcript
Protective Barrier Enclosure Emergency Use Authorizations (EUAs)
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Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic
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Gowns - Regulatory Responsibilities
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Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic
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Enforcement Policy for Bioburden Reduction Systems Using Dry Heat to Support Single-User Reuse of Certain Filtering Facepiece Respirators during the COVID-19 Pandemic
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Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic
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Transitioning from the Use of Decontaminated Disposable Respirators
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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
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Regulatory Science Tools
Targeted Box and Blocks Test (tBBT)
Presentation Transcript
Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions, Final Guidance
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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
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Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile Final Guidance
Presentation Printable Slides Transcript
Medical Device Sterilization Town Hall Series (Updated 12/20/24)
| Series Number | Topic | Date | Materials |
|---|---|---|---|
| 01 | Medical Device Sterilization Town Hall Overview | 01/10/2024 | Presentation Transcript Slides |
| 02 | FDA’s Sterilization Related Activities | 01/26/2024 | Presentation Transcript Slides |
| 03 | Premarket Pt 1: New submissions & considerations | 02/07/2024 | Presentation Transcript Slides |
| 04 | Premarket Pt 2: Modifications and Master Files | 02/29/2024 | Presentation Transcript Slides |
| 05 | Premarket Pt 3: Use of Standards & Standards Development | 03/21/2024 | Presentation Transcript Slides |
| 06 | Topics and Formats for the Continuing Town Hall Series | 04/29/2024 | Presentation Transcript Slides |
| 07 | Sterilization Method Selection | 05/23/2024 | Presentation Transcript Slides |
| 08 | Sterilization Open Q&A | 06/12/2024 | Presentation Transcript Slides |
| 09 | Mock Pre-Submission for Sterilization Method Change | 07/10/2024 | Presentation Transcript Slides |
| 10 | Bioburden, bacterial endotoxin and packaging integrity testing for sterile medical devices | 08/07/2024 | Presentation Transcript Slides |
| 11 | Effective use of Sterility Master Files | 09/11/2024 | Presentation Transcript Slides |
| 12 | Predetermined Change Control Plans (PCCPs) | 10/09/2024 | Presentation Transcript Slides |
| 13 | Supporting medical device innovators and bundling sterility submissions | 10/30/2024 | Presentation Transcript Slides |
| 14 | Recognized consensus standards and biocompatibility assessment considerations | 11/20/2024 | Presentation Transcript Slides |
| 15 | New transitional enforcement policy, VH2O2 diffusion research/modeling, series updates, wrap up and next steps | 12/04/2024 | Presentation Transcript Slides |
How to Get Your Electronic Product on the U.S. Market
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Electronic Product Certification and Quality Testing Programs
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Marketing Clearance of Diagnostic Ultrasound Systems and Transducers: Final Guidance
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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
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510(k) Third Party Review Program: Final Guidance510(k) Third Party Review Program: Final Guidance
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Overview of the 510(k) Process: Guide for Third Party Reviewers
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Deficiency Writing for Third Party Reviewers
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Deficiency Writing for Third Party Reviewers: Examples
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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
Resources
Device Advice
Device Advice is CDRH's premier text-based resource for comprehensive regulatory education that explains medical device laws, regulations, guidances, and policies, across the entire product life cycle.
CDRH Webinars
CDRH Webinars feature FDA presentations and live stakeholder question and answer discussions about timely medical device laws, regulations, guidances, or programs.
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