CDRH Learn
Welcome to CDRH Learn! CDRH Learn is our multi-media educational resource, featuring learning modules that address medical device and radiation emitting product laws, regulations, guidances, and policies, across the entire product life cycle. These modules provide industry with information that is comprehensive, interactive, and easily accessible. Modules are provided in various formats, including videos, audio recordings, and slide presentations.
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Start Here/The Basics! (Updated Module 10/16/2023)
MDUFA Small Business Program, Registration and ListingAn Introduction to FDA's Regulation of Medical Devices
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How is CDRH Structured?
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Is My Product a Medical Device?
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An Introduction to the Medical Device User Fee Program: MDUFA V (New 7/19/23)
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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
How to Complete Form FDA 3602A: MDUFA Foreign Small Business Certification Request For a Business Headquartered Outside the United States
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Registration and Listing (Updated 10/16/23)
Device Registration and Listing: An Introduction – Part 1 (Updated 10/16/23)
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Device Registration and Listing: An Introduction – Part 2 (Updated 10/16/23)
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Paying the Annual Registration User Fee via the Device Facility User Fee (DFUF) Website
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FURLS Device Registration and Listing Module for Annual Registration
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FURLS Device Registration and Listing Module for Initial Registration
Presentation
How to Study and Market Your Device - (Updated 11/20/23)
510k, De Novo, IDE, PMA, HUD/HDE, Q-Submissions, Standards, ClassificationPremarket Notification (510k)
The 510(k) Program
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CDRH's New Draft Guidances to Continue to Modernize the 510(k) Program (Updated 11/3/23)
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The Special 510(k) Program: Final Guidance
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Safety and Performance Based Pathway Criteria for Certain Device Types Final Guidances
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Safety and Performance Based Pathway Performance Criteria
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Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics
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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"
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De Novo
De Novo Final Rule: Overview and Guidance Updates
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De Novo Program
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Clinical Studies/Investigational Device Exemption (IDE)
IDE Basics
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Implementation of Final Rule on Human Subject Protection: Acceptance of Data from Clinical Investigations for Medical Devices
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Final Guidance on Adaptive Designs for Medical Device Clinical Studies
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An Update on the FDA's Medical Device Clinical Trials Program
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Breakthrough Devices Program, Updated Final Guidance [2023] (Updated 11/20/2023)
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Breakthrough Devices Program [2019]
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Strengthening the Medical Device Clinical Trial Enterprise
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IDEs for Early Feasibility Medical Device Clinical Studies, Including First in Human (FIH) Studies
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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
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Post-Approval Study Requirements and Postmarket Surveillance under Section 522 of the Federal Food, Drug, and Cosmetic Act, Final Guidances
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FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions
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Premarket Approval Application (PMA)
Introduction to the Premarket Approval Application (PMA) Program
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Premarket Approval Application (PMA) Program: Postapproval Requirements
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Humanitarian Use Device (HUD)/Humanitarian Device Exemption (HDE)
Module 1: Office of Orphan Products Development
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Module 2: Humanitarian Use Device (HUD): Program Overview
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Module 3: Humanitarian Device Exemption (HDE): Program Overview and Pre-approval Activities
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Module 4: Humanitarian Device Exemption (HDE): Post-approval Activities
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Humanitarian Device Exemption Program
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Q-Submissions
Q-Submission Program for Medical Device Submissions
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Requests for Feedback: The Pre-Submission Program and Meetings with FDA Staff
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Standards
Module 1: Standards Overview
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Module 2: Standards Resources and Premarket Use
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Module 3: CDRH Standards Recognition Process
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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
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Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Final Guidances
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Appropriate Use of Voluntary Consensus Standards
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Recognition and Withdrawal of Voluntary Consensus Standards - Final Guidance
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Cross-Cutting Premarket Policy
CDRH Portal Overview and Feature Walkthrough (New 9/29/23)
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Safer Technologies Program: Draft Guidance
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Combination Product Updates for "Acceptance and Filing Reviews for Premarket Approval Applications" and "Refuse to Accept Policy for 510(k)s"
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Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
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Patient Preference Information
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Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices
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Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications
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The Least Burdensome Provisions: Concept and Principles Final Guidance
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Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions
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Multiple Function Device Products: Policy and Considerations
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Classification
How is My Medical Device Classified?
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Case Study: How is My Medical Device Classified?
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513(g) Requests for Information
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Final Guidance on Medical Device Accessories: Describing Accessories and Classification Pathway for New Accessory Types
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Bioresearch Monitoring (BIMO)
BIMO Part 1 - Introduction to the Bioresearch Monitoring Program
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BIMO Part 3a - Institutional Review Board: Responsibilities in Making the Significant Risk and Non-significant Risk Device Determination
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BIMO Part 3b - Institutional Review Board: Humanitarian Use Devices (HUDs)
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BIMO Part 4c - Preparing for an FDA Institutional Review Board Inspection
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BIMO Part 5a - Strategies for Sponsors to Build Quality into Device Research
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BIMO Part 5b - Strategies For Clinical Investigators to Build Quality into Device Research
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Postmarket Activities
Quality System, Exporting, Device Recalls, MDR, Inspection - Global HarmonizationOverview of the Quality System
Start Here! Overview of the Quality System
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Production and Process Controls
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Production and Process Controls, Part 2
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Documents, Change Control, and Records
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Design Controls
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Risk Basics for Medical Devices
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Application of Risk Management Principles for Medical Devices
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Management Controls
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Purchasing Controls
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Process Validation
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Corrective and Preventive Actions
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Nonconforming Product
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Complaint Files
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Exports and Imports
Exporting Medical Devices
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Importing Medical Devices Into the United States
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General Policy
Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency
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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
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Computer Software Assurance for Production and Quality System Software, Draft Guidance
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Medical Device Recalls
Distinguishing Medical Device Recalls from Medical Device Enhancements
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Introduction to Medical Device Recalls: Industry Responsibilities
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Recall Module 21 CFR Part 806: Medical Devices; Reports of Corrections and Removals
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Electronic Submission of 806 Reports of Corrections and Removals
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Recall Communication: Medical Device Model Press Release
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Recall Communication: Medical Device Model Recall Notification Letter
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Medical Device Recalls: Guidance for Industry
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Medical Device Reporting (MDR)
Overview of Medical Device Reporting
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Medical Device Reporting for Mandatory Reporters
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Electronic Medical Device Reporting (eMDR)
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Final Guidance on Medical Device Reporting for Manufacturers
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eMDR eSubmitter and WebTrader Tutorial
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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 12/19/23)
IVD Development, CLIA, and Virtual Town Hall SeriesProposed Rule: Medical Devices; Laboratory Developed Tests (Updated 11/3/23)
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3D Printed Swabs
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Antimicrobial Susceptibility Test System Devices - Updating Breakpoints in Device Labeling (Updated 12/18/23)
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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
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Final Guidances on Next Generation Sequencing-based Tests
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Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program (Updated 12/19/23)
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Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product
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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
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2. Global Unique Device Identification Database (GUDID) Account Request: Preparation and Process
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3. The GUDID Device Identifier (DI) Record
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4. GUDID HL7 SPL Submission Option
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5. Optimizing GUDID Data Quality
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6. Unique Device Identification: Direct Marking of Devices Final Guidance
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7. Unique Device Identification: Convenience Kits, Final Guidance
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COVID-19 Transition Policy
COVID-19 Transition Policy for Devices, Final Guidances
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Device-Specific Topics
Dental Devices Premarket Submissions
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Final Guidance on "General Wellness: Policy for Low-Risk Devices"
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Digital Health Software Precertification (PreCert) Pilot Program
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Hearing Aids and Personal Sound Amplification Products
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Overview of the Final Order calling for PMAs for AEDs
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Self Monitoring Blood Glucose Systems for Over-the-Counter Use & Blood Glucose Monitoring Systems for Prescription Point-of-Care Use
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Animal-Related Policy
Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) Final Guidance
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Biocompatibility
Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process” - Final Guidance [2023] - (Updated 10/24/23)
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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]
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Color Additives
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Collaboration
Collaborative Communities: Addressing Healthcare Challenges Together
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Custom Devices
Custom Device Exemption
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Technical Considerations for Additive Manufactured Medical Devices
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Digital Health
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions
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Content of Premarket Submissions for Device Software Functions, Final Guidance
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Digital Health
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Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices Final Guidance
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Clinical Decision Support Software, Final Guidance
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Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act: Final Guidance
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Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - Final Guidance (Updated 11/17/2023)
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Postmarket Management of Cybersecurity in Medical Devices Final Guidance
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Digital Health Center of Excellence Listening Session #1
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Digital Health Center of Excellence Listening Session #2
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Human Factors
Applying Human Factors and Usability Engineering to Medical Devices
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Home Use
FDA's Home Use Medical Device Initiative
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Promoting Patient Safety with Home Use Devices
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Home Use Medical Devices: New Risks
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Medical Devices in the Home: Design Considerations and Guidance for Industry
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Medical Imaging
Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment
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Neurological Devices
Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder: Draft Guidance (Updated 9/19/23)
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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
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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
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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
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Regulation of Face Masks and Surgical Masks During the COVID-19 Pandemic - August 4, 2020
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FDA's Surgical Masks Umbrella EUA - August 18, 2020
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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
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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
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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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Regulatory Science Tools
Qualification of Medical Device Development Tools: Final Guidance (Updated 9/19/23)
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Targeted Box and Blocks Test (tBBT)
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Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions, Final Guidance (Updated 1/22/24)
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Reprocessing
Webinar - Duodenoscope Sampling and Culturing
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Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
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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
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Medical Device Sterilization Town Hall Series (Updated 2/28/24)
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 | 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
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Phantom Image Scoring (For MQSA Inspectors)
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eSubmitter Tutorial Presentations
eSubmitter Tutorial Presentations Radiological Health Report Tutorial
510(k) Third Party Review Program: Overview
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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
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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
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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.
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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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