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- NHRA Draft Guidance on Online Medical Devices Importation Approval: Overview
- MDA Guidance on Combination Products: Timelines, Fees, and Changes
- MDA Guidance on Combination Products: Registration Process
- DRAP Guidance on Reliance Mechanism in Regulatory Processes: Overview
- MDA Guidance on Combination Products: Overview
- NHRA Guidance on Medical Devices Registration: Variations
- NHRA Guidance on Medical Device Registration: Overview
- HSA Guidance on Adverse Events Reporting: Details
- HSA Guidance on Reclassification: Medical Devices to be Introduced Into the Body
- HSA Guidance on Adverse Events Reporting: IVDs and Timelines
- HSA Guidance on the Reporting of Adverse Events: Overview
- HSA Guidance on Medical Device Advertisements and Sales Promotion: Specific Rules and Corrective Measures
- HSA Guidance on Advertising and Promotion: General Principles
- HSA Guidance on Medical Device Advertisements and Sales Promotion: Overview
- HSA Guidance on Importation of Unregistered Medical Devices for Exhibition: Specific Aspects
- HSA Guidance on Importation of Unregistered Devices for Exhibition: Overview
- HSA Guidance on Cancellation of a Medical Device: Overview
- HSA Guidance on Change of Registrant: Overview
- HSA Guidance on Change Notification for EU MDR/IVDR Related Changes
- HSA Guidance on Change Notifications: Implementation Process
- HSA Guidance on Change Notification: Application Process
- HSA Guidance on Change Notification: Change Type Flowcharts
- HSA Guidance on Change Notification: FSCA-related Changes and Exemptions
- HSA Guidance on Change Notification: Categories of Changes
- HSA Guidance on Change Notification: Overview
- HSA Guidance on GDP: Internal Audits and Outsourcing
- HSA Guidance on GDP: Counterfeit Devices and Complaint Handling
- HSA Guidance on GDP: Good Assembly Practice and Traceability
- HSA Guidance on SAR: Post-Market Obligations and Summary
- HSA Guidance on Standard GDP: Key Principles of Secondary Assembly
- HSA Guidance on Special Access Routes: Requirements
- HSA Guidance on Good Distribution Practice: Delivery, Installation, and Servicing
- HSA Guidance on Special Access Routes: Overview
- HSA Guidance on GDP: Storage Conditions and Principles
- HSA Guidance on Good Distribution Practice: Overview
- HSA Guidance on UDI System: Implementation Timeline
- HSA Guidance on UDI System: Information Submission Details and Device-specific Rules
- HSA Guidance on UDI System: New e-service and Change Notification
- HSA Guidance on UDI System: UDI Development and Placement
- HSA Guidance on UDI System: Components and Labeling
- New HSA Guidance on UDI: Overview
- HSA Guidance for Dealers on Class A Medical Devices: Overview
- HSA Guidance on Establishment Licenses: Renewal, Suspension, and Inspections
- HSA Guidance on Establishment Licenses: Changes to Dealer’s License Information
- DRAP Guidance on Clinical Trials Applications: Documents
- NHRA Guidance on Medical Device Importation Approval: General Rules and Specific Aspects
- HSA Guidance on Establishment Licensing: Overview
- DRAP Guidance on Clinical Trials: Registries and Investigator’s Brochure
- HSA Guidance on Establishment Licensing: Overview
- DRAP Guidance on Clinical Trials Applications: CGP Compliance Audits and Reports
- HSA Guidance on Essential Principles: Supply-Related Risks, Combination Products, and IVDs
- HSA Guidance on Essential Principles: Radiation, Lay Persons, Biological Materials
- DRAP Guidance on Clinical Trials: Import, Timelines, and Ethical Approval
- HSA Guidance on Essential Principles: Device-Specific Principles and Risks
- DRAP Guidance on Clinical Trials: Application in Detail
- HSA Guidance on Essential Principles: Sterility and Use Environment
- DRAP Guidance on Clinical Trials Applications: Overview
- HSA Guidance on Essential Principles: General Provisions and Clinical Trials
- HSA Guidance on Essential Principles: Standards and Applicability
- HSA Guidance on Essential Principles: Overview
- NHRA Guidance on Medical Device Importation Approval: Overview
- HSA Guidance on Change Notification: Specific Aspects
- HSA Guidance on Change Notification Requirements: Application Process
- HSA Guidance on Change Notification: Overview
- HSA Guidance on Declaration of Conformity
- Turkish Regulation on Clinical Trials: Specific Aspects
- HSA Guidance on Clinical Evaluation: Analysis of the Clinical Data
- Turkish Regulation on Clinical Trials: Reports and Responsibilities
- HSA Guidance on Clinical Evaluation: Data Types and Appraisal
- DRAP Guidance on Imports & Exports of Therapeutic Goods: Overview
- HSA Guidance on Data Sources for Clinical Evaluation: Literature Review
- HSA Guidance on Clinical Evaluation: General Principles
- HSA Guidance on Clinical Evaluation: Overview
- HSA Guidance on Grouping of Medical Devices: Grouping Categories
- HSA Guidance on Grouping of Medical Devices: Overview
- HSA Guidance on IVD Classification
- HSA Guidance on Labeling for Medical Devices: Implantable Devices and IVDs
- HSA Guidance on Labeling: Content of Labeling
- Turkish Regulation on Clinical Trials: Responsibilities of the Parties
- Turkish Draft Regulation on Clinical Trials: Basics
- HSA Guidance on Labeling for Medical Devices: Introduction
- Circular on Renewal of Medical Device Licenses – Jordan
- HSA Guidance on Product Registration Submissions: ASEAN CSDT in Detail
- HSA Guidance on Preparation of a Product Registration Submission: Overview
- New Turkish Regulation on Quality Compliance and Control Tests
- HSA FAQ on 3D-Printed Medical Devices: Basics
- HSA Guidance on Telehealth Products: Classification and Regulatory Controls
- HSA Guidance on Telehealth Products: Basics
- HSA Guidance on Risk Classification of General Medical Devices: Classification Rules in Detail
- PADC Guidance on Registration of High-Risk Medical Devices: Annexes
- HSA Guidance on Classification of General Medical Devices: General Principles
- HSA Guidance on a Life Cycle Approach for AI-based Medical Devices: Specifics, Post-market Monitoring and Changes
- HSA Guidance on Life Cycle Approach for AI-based Devices: Regulatory Basics
- HSA Guidance on Life Cycle Approach for Software Medical Devices: Cybersecurity
- HSA Guidance on Post-Market Management of Software Medical Devices
- HSA Guidance on Life Cycle Approach for Software Medical Devices: Activity Controls and Change Notification
- HSA Guidance on Software Medical Devices: Pre-Market Product Registration Requirements
- HSA Guidance on Software Medical Devices: Basics
- HSA Guidance on 3D-printed Medical Devices
- Oman Guidance on Medical Devices Bundling / Grouping Criteria
- HSA Guidance on IVD Analyzers: SMDR Listing Options
- Oman Guidance on Fast Track High-Risk Medical Devices Registration
- HSA Guidance on IVD Analyzers
- HSA Guidance on Medical Device Advertisements
- HSA Guidance on Medical Device Product Registration: Additional Aspects
- HSA Guidance on Medical Device Advertisement: Basics
- HSA Draft Guidance on Qualification of CDSS
- HSA Consultation on Risk Classification of Standalone Medical Mobile Applications (SaMD)
- HSA Guidance on UDI Implementation Process
- HSA Guidance on Medical Device Unique Device Identification System
- Philippines on Licensing Inspection for Radiation Facilities
- HSA Announces Singapore’s UDI System
- Thailand FDA on Direct Advertising and Labeling
- Taiwan on Registration of Single-Use Medical Devices
- MDA Guidance on Conformity Assessment Body Registration
- Taiwan on Medical Device Safety Monitoring and Surveillance
- Taiwan Draft Guidance on Adverse Event Reporting
- FDA on Water-Circulating Hot/Cold Therapy Devices
- MDA on Requirements for Conformity Assessment Bodies
- MDA on Complaint Handling and Problem Reporting
- MDA Guidance on Field Corrective Action
- PMDA on Cybersecurity Assurance of Medical Devices
- An Overview of South Korea and Their Medical Devices
- Japan Issues Updated Guidance on Biocompatibility Testing
- Japan Amends Medical Device Regulations
- Philippines New Medical Device Regulation Framework
- MFDS New Guidance on Imported and Scarce Medical Devices
- Classification Guidelines for Medical Devices in Bangladesh
- Vietnam Amends Medical Device Regulations – 2019
- MFDS Amended Submission Requirements
- MDA Malaysia’s Guidance on Combination Products
- CDSCO Designates Six Bodies To Perform Manufacturing Site Audits
- Saudi Prepares to Improvise Their Medical Devices Regulation
- Turkey Updates Its Medical Device Regulations
- Medical Device Reimbursement in Japan
- An Overview of Medical Device Regulations in Japan
- Meet this Month’s #WebinarWednesday Speaker: Yoojin Ahn
- Our Guide for How to Register Medical Devices in India
- An Overview of Medical Device Regulations in China
- Philippines FDA Has New Medical Device Regulations in the Pipeline
- MHRA Begins Sharing Intelligence with India to Halt Unlicensed Drug Imports
- India CDSCO Transitions to Online Portal for Blood Products
- Chinese CFDA Adds More Devices Exempt from Clinical Trials
- Saudi Arabia Issues Final Guidance on Medical Device National Registry Route
- India to Authenticate Drugs from Top 300 Pharmaceutical Companies
- #WebinarWednesday Sneak Peek: Medical Device Regulations in Pakistan
- What You Need to Know About Pakistan’s New Medical Device Regulations
- Singapore’s HSA Enhances Legislation to Facilitate Faster Access to Medical Devices
- Malaysian Medical Device Regulations to go into Effect July 1
- India’s CDSCO Plans to Regulate High-End Medical Equipment and Implantable Devices
- Regulatory Roundup from Bahrain
- Answers to Your Most Critical IVD Questions for India
- How Could Changing Manufacturing Facilities Impact Your Device Company?
- China’s CFDA Issues Record Keeping Requirements for Clinical Trial Institutions
- Is There an Pathway for Our Combination Device regulations in Korea, India, Taiwan, and China?
- 4 Things You Need to Know About India’s Notified Bodies
- India’s New Medical Device Regulations: 10 Things You Need to Know
- CFDA Seeks to Streamline Regulations to Align with Other Regulatory Bodies
- CFDA Promises to Accelerate Some Drug Approvals
- Things You Need to Know Before Doing Medical Device Business in Japan
- China Priority Review Option Now Available for Medical Devices
- Quick Primer of the New Device Regulations in India
- Perceived Inconsistency in the Requirements of Clinical Data in Japan
- Medical Device Registration Process in Vietnam
- China’s Solution to Shortage of Vaccines
- New CFDA Regulations on Device Clinical Trials
- CFDA Publishes New Medical Device Naming Rule
- China to Stop Drug Operation for Pharma Companies that Don’t Pass New GSP
- Get to Know: South Asia Regulatory Authorities
- Get to Know: East Asia Regulatory Authorities
- List of Recognized Medical Device Standards Issued By Hong Kong
- Global Medical Device Regulations 101
- How to Register Your Medical Device in India
- FDA Guidance on 510(k) and Review Clock: Overview
- FDA Guidelines on Medical Device Classification: Overview
- FDA Guidance on Viral Mutations: Antigen Diagnostic Tests
- FDA Guidance on PBM Devices: Wireless Technology, Thermal and Eye Safety
- FDA Policy on Viral Mutations: Molecular Diagnostic Tests
- FDA Guidance on Photobiomodulation Devices: Usability and EMC
- FDA Guidance on Viral Mutations: General Principles
- FDA Draft Guidance on the Content of Human Factors Information: Recommendations
- FDA Draft Guidance on VMSR Program: Scope and General Conditions
- FDA Draft Guidance on PBM Devices: Predicate Comparison and Labeling
- FDA Draft Guidance on PBM Devices: Reprocessing, Biocompatibility and Software
- FDA Policy on Viral Mutations: Overview
- FDA Revised Policy for COVID Tests: Key Points
- FDA Draft Guidance on the Content of Human Factors Information: Recommendations
- FDA Guidance on Content of Human Factors Information: Overview
- FDA Guidance on Design Considerations for Pivotal Clinical Investigations: Investigation Plan and Definitions
- FDA Guidance on Sustaining the Quality of Clinical Studies: Study Analysis and Changes to Pivotal Studies
- FDA Draft Guidance on Denying or Limiting an Inspection
- FDA Guidance on Sustaining the Quality of Clinical Studies: Study Conduct
- FDA Draft Guidance on Delaying an Inspection: Reasonable and Unreasonable Delays
- FDA Draft Guidance on VMSR Program: Supplemental Reports and Summary Reporting
- FDA Draft Guidance on Inspection Delays: Overview
- FDA Guidance on VMSR Program: Special Conditions
- FDA Draft Guidance on VMSR Program: Scope and General Conditions
- FDA Draft Guidance on Human Factors Information: Risk-Based Approach
- FDA Draft Guidance on VMSR Program: Product Code Eligibility
- FDA Draft Guidance on VMSR Program: Principles and Eligibility Determination
- FDA Draft Guidance on Voluntary Malfunction Summary Reporting Program: Overview
- FDA Guidance on Design Considerations for Pivotal Clinical Investigations: Sustaining the Quality of Clinical Studies
- FDA Guidance on Post-Approval Studies: Failure to Comply and Disclosure
- FDA Guidance on Diagnostic Clinical Performance Studies: Preventing Bias
- FDA Guidance on Post-Approval Studies: Status Categories
- FDA Guidance on Diagnostic Clinical Performance Studies: Population, Planning, Selection
- FDA Guidance on Post-Approval Studies: Evaluation
- FDA Guidance on Diagnostic Clinical Performance Studies: Key Points
- FDA Guidance on Referencing the Definition of “Device”: Overview
- FDA Guidance on Design Considerations for Pivotal Clinical Investigations: Placebo Effect
- FDA Guidance on Ethical Considerations for Clinical Investigations Involving Children: Study Procedures and Summary
- FDA Guidance on Design Considerations for Clinical Outcome Studies: Controls
- FDA Guidance on Ethical Considerations for Clinical Investigations Involving Children: Design Considerations
- FDA Guidance on Design Considerations for Pivotal Clinical Investigations: Intervention Assignment and Masking
- FDA Guidance on Ethical Considerations for Clinical Investigations Involving Children: Parental Permission and Supporting Data
- FDA Guidance on Design Considerations for Pivotal Clinical Investigations: Endpoints
- FDA Guidance on Ethical Considerations for Clinical Investigations Involving Children: Direct Benefit
- FDA Guidance on Design Considerations for Pivotal Clinical Investigations: Stratification and Site Selection
- FDA Guidance on Ethical Considerations for Clinical Investigations with Children Involved: Principles and Risk Categories
- FDA Guidance on Design Considerations for Pivotal Clinical Investigations: Study Objectives and Selection
- FDA Guidance on Ethical Considerations for Clinical Investigations: Overview
- FDA Guidance on Design Considerations of Pivotal Clinical Investigations: General Principles, Bias and Variability
- FDA Guidance on Distinguishing Medical Device Recalls from Enhancements: Identifying a Recall
- FDA Guidance on Design Considerations for Pivotal Clinical Investigations: Types of Medical Devices
- FDA Guidance on Distinguishing Medical Device Recalls from Enhancements: Key Concepts and Definitions
- FDA Guidance on Design Considerations for Pivotal Clinical Investigations: Evidence-Related Matters
- FDA Guidance on Distinguishing Recalls From Enhancements: Overview
- FDA Guidance on Design Considerations for Pivotal Clinical Investigations: Evidence
- FDA Guidance on Abbreviated 510(k) Program: Overview
- FDA Guidance on Design Considerations for Pivotal Clinical Investigations: Overview
- FDA Guidance on Production Software Assurance: Record-Keeping
- FDA on Low-Risk Devices: Determining the Risk
- Philippines Guidance on Abridged Processing of Applications: Overview
- FDA Guidance on Production Software Assurance: Appropriate Assurance Activities
- FDA Guidance on Low-Risk Devices: Overview
- FDA Guidance on Production Software Assurance: Risk-Based Approach
- FDA Guidance on the Least Burdensome Approach: Timing
- FDA Guidance on Computer Software Assurance: Determination
- FDA Guidance on the Least Burdensome Approach: Smart Regulation and Global Harmonization
- FDA Guidance on Monkeypox Tests: Specific Aspects
- FDA Guidance on the Least Burdensome Approach: Streamlining the Process
- FDA Guidance on Monkeypox Tests: Modifications, Notification Content, and Reporting
- FDA Guidance on the Least Burdensome Approach: Clinical Studies and Benefit-Risk Assessments
- FDA Guidance on Monkeypox Tests: Initial Authorization
- FDA Guidance on Computer Software Assurance: Overview
- FDA Guidance on the Least Burdensome Approach: The Minimum Information Necessary
- FDA Guidance on Monkeypox Tests: Overview
- FDA Guidance on SR and NSR Studies: FDA Responsibilities and Examples
- FDA Guidance on the Least Burdensome Approach: Guiding Principles
- FDA Guidance on SR and NSR Studies: IRBs’ Responsibilities
- FDA Guidance on Least Burdensome Provisions: Overview
- FDA Guidance on Significant Risk and Nonsignificant Risk Medical Device Studies: Overview
- FDA Guidance on Manufacturing Information in PMAs: Specific Aspects
- FDA Guidance on Medical Device Patient Labeling: Pretesting
- FDA Guidance on Manufacturing Information and Operations in PMAs: Review Process
- FDA Guidance on Medical Device Patient Labeling: Warnings and Precautions
- FDA Guidance on Review and Inspection of PMA: Overview
- FDA Guidance on Patient Labeling: Appearance of Text and Graphics
- FDA Guidance on IDEs for NHHDs: Training and Labeling in Investigational Plan
- FDA Guidance on Medical Device Patient Labeling: Readability
- FDA Guidance on NHHD Systems: Investigation Plan
- FDA Guidance on Medical Device Patient Labeling: Troubleshooting and Additional Information
- FDA Guidance on IDEs for NHHDs: Reports of Prior Investigation
- FDA Guidance on Medical Device Patient Labeling: Operational Information
- FDA Guidance on NHHD: Physical and Electronic Characteristics; Functions and Features
- FDA Guidance on Medical Device Patient Labeling: Descriptive Information
- FDA Guidance on IDEs for Nocturnal Home Hemodialysis: Overview
- FDA Guidance on Medical Device Patient Labeling: Specific Aspects
- FDA Guidance on PMA Supplement Decision-Making Process: Changes to Manufacturing Site and Periodic Reports
- FDA Guidance on Medical Device Patient Labeling: Overview
- FDA Guidance on PMA Decision-Making Process: 30-Day Supplement
- FDA Guidance on PMA Decision-Making Process: Special PMA Supplement
- FDA Guidance on Home Use Devices: Postmarket Considerations
- FDA Guidance on PMA Supplement Decision-Making Process: Real-Time Supplement
- FDA Guidance on Home Use Devices: Labeling
- FDA Guidance on PMA Supplement Decision-Making Process: 180-Day Supplement
- FDA Guidance on Home Use Devices: Human Factors
- FDA Guidance on PMA Supplement Decision-Making Process: Panel-Track Supplement
- FDA Guidance on Home Use Devices: Electrical Issues
- FDA Guidance on the PMA Supplement Decision-Making Process: Traditional PMA
- FDA Guidance on Home Use Devices: Design Considerations
- FDA Guidance on the PMA Supplement Decision-Making Process: Overview
- FDA Guidance on Home Use Devices: User Considerations
- FDA Guidance on Home Use Devices: Environmental Considerations
- FDA Guidance on Manufacturing Site Changes Supplements: Submission Content
- FDA Guidance on Home Use Devices: Overview
- FDA Guidance on Manufacturing Site Change Supplements: Submission Type Determination
- FDA Guidance on Manufacturing Site Change Supplements: Overview
- FDA Guidance on Quantitative Imaging: Specific Aspects
- FDA Guidance on Quantitative Imaging: Overview
- FDA Guidance on Tissue Containment Systems: Non-Clinical Performance Testing
- FDA Guidance on Quantitative Imaging: Overview
- FDA Draft Guidance on Tissue Containment Systems: Overview
- FDA on Electromagnetic Compatibility of Medical Devices: Modifications and Labeling
- FDA on Heater-Cooler Devices
- FDA Guidance on Electromagnetic Compatibility: Testing, Allowances, and Deviations
- FDA Guidance on Sterility Information: Overview
- FDA Guidance on Electromagnetic Compatibility: Standards and Testing
- FDA Guidance on Orthopedic Fracture Fixation Plates: Testing a Validation
- FDA Guidance on Electromagnetic Compatibility of Medical Devices: Overview
- FDA Guidance on Orthopedic Fracture Fixation Plates: Overview
- FDA Guidance on Quality System Information: Specific Aspects
- FDA Q&A on eMDR: Overview
- FDA Guidance on VIP: Modified Submission Formats
- FDA Guidance on Voluntary Improvement Program: Flow and Activities
- FDA Guidance on Fostering Medical Device Improvement: Key Points
- FDA on Clinical Studies for Glycemic Control Devices: Specific Aspects
- FDA Guidance on a Safer Technologies Program: Mechanisms for Feedback
- FDA Guidance on Clinical Studies for Glycemic Control Devices: Duration and Inclusion/Exclusion Criteria
- FDA Guidance on STeP: Additional Considerations for Entrance Review
- FDA Guidance on Clinical Studies for Glycemic Control Devices: Overview
- FDA Guidance on Safer Technologies Program: Eligibility Factors
- FDA Guidance on Facet Screw Systems
- FDA Guidance on Safer Technologies Program: Principles
- FDA Guidance on Quality System Information: Manufacturing Details
- FDA Safer Technologies Program: Overview
- FDA Guidance on Quality System Information: Design Control Information
- FDA Guidance on Quality System Information: Overview
- FDA Guidance on Substantial Equivalence: Requests for Performance Data
- FDA Guidance on IDEs for Early Feasibility Studies: Specific Aspects
- FDA Guidance on Substantial Equivalence: Technological Characteristics
- FDA Guidance on IDEs for Early Feasibility Studies: Iterations
- FDA Guidance on Substantial Equivalence: Intended Use
- FDA Guidance on Investigational Device Exemptions: Investigation Plan
- FDA Guidance on Human Factors: Specific Aspects
- FDA Guidance on IDEs For Early Feasibility Studies: Specific Aspects of Prior Investigations
- FDA Guidance on IDEs For Early Feasibility Studies: Device Evaluation Strategy
- FDA Guidance on Human Factors Validation Testing: Analysis and Residual Risk
- FDA Guidance on IDEs for Early Feasibility Studies: Report of Prior Investigations
- FDA Guidance on Simulated-Use Human Factors Validation Testing: Data Collection
- FDA Guidance on Early Feasibility Study IDEs: Key Points
- FDA Guidance on Human Factors Validation Testing: Simulated Use and Participants
- FDA Guidance on Elimination of Use-Related Hazards and Human Factors Validation Testing
- FDA Guidance on IDEs for Early Feasibility Studies: an Overview
- FDA Guidance on Human Factors and Usability Engineering: Formative Evaluation
- FDA Guidance on Evaluation of Substantial Equivalence: Predicate Devices
- FDA Guidance on Human Factors and Usability Engineering: Analytical and Heuristic Approaches
- FDA Guidance on Substantial Equivalence: Categories and Decision-Making Flowchart
- FDA Guidance on Human Factors and Usability Engineering: Critical Tasks Assessment
- FDA Guidance on Substantial Equivalence in Premarket Notifications: Review Standard
- FDA Guidance on Human Factors and Usability Engineering: Users, Environment, Interface
- FDA Guidance on Human Factors and Usability Engineering: Overview
- FDA Guidance on Additive Manufactured Medical Devices: Material Characterization
- FDA Guidance on PRO Instruments: Best Practices
- FDA Guidance on Patient-Reported Outcome Instruments: Key Principles in Brief
- FDA Guidance on Additive Manufactured Medical Devices: Testing Considerations
- FDA Guidance on Patient Engagement: Policy in Detail
- FDA Guidance on Patient Engagement: Introduction
- FDA Guidance on Additive Manufactured Medical Devices: Material Controls, Post-Processing, and Validation
- FDA Guidance on Additive Manufactured Medical Devices: Software-Related Aspects
- FDA Guidance on Evaluating Substantial Equivalence in Premarket Notifications: Overview
- FDA Guidance on Medical Device Reporting: Additional Clarifications
- FDA Guidance on Additive Manufactured Medical Devices: Design Process in Brief
- FDA Guidance on Additive Manufactured Medical Devices: Definitions and Overview
- FDA Guidance on Medical Device Reporting: Completion of the Report
- FDA Guidance on Medical Device Reporting: Specific Cases
- FDA Guidance on Software Validation: Automated Process Equipment and Quality System Software
- FDA Guidance on Additive Manufactured Medical Devices: Basics
- FDA Guidance on Software Validation: User Site Testing and Maintenance
- FDA Guidance on GUDID Requirements for Certain Devices: Revised Policy
- FDA Guidance on the Content of Premarket Submissions for Device Software Functions: Additional Aspects
- FDA Guidance on General Principles of Software Validation: Changes and Testing Levels
- FDA Guidance on GUDID: Account Roles
- FDA Guidance on Content of Premarket Submissions for Device Software Functions: Development and Testing
- FDA Guidance on the Safety and Performance Based Pathway: Policy in Detail
- FDA Guidance on the Content of Premarket Submission for Device Software Functions: Documents in Detail
- FDA Guidance on Safety and Performance Based Pathway
- FDA Draft Guidance on Content of Premarket Submissions for Device Software Functions: Introduction
- FDA Guidance on Premarket Submissions for Device Software Functions: Definitions and Documentation
- FDA Guidance on GUDID: Modules
- FDA Guidance on Software Validation Activities: Testing by the Developer
- FDA Guidance on GUDID: Device Identifier (DI) Record
- FDA Guidance on Software Validation Tasks: Design and Coding
- FDA Guidance on De Novo Classification Requests and Review Clock: Requester’s Actions
- FDA Guidance on Surgical Staplers and Staples – Technical Characteristics
- FDA Guidance on De Novo Requests: Review Clock and Goals
- FDA Guidance on Surgical Staplers and Staples for Internal Use – Labelling Recommendations
- FDA Guidance on Software Validation: Activities and Tasks in Brief
- FDA Guidance on GUDID Account: Key Concepts
- FDA Guidance on De Novo Requests and Effect on FDA Review Clock and Goals: FDA Actions
- FDA Guidance on GUDID: Key Points
- FDA Draft Guidance on Hearing Aid Devices
- FDA Guidance on Postmarket Management of Cybersecurity: Additional Aspects
- FDA Guidance on Principles of Software Validation
- FDA Guidance on Remanufacturing Medical Devices: Specific Aspects
- FDA Guidance on Cybersecurity: Remediating and Reporting Cybersecurity Vulnerabilities
- FDA Guidance on Software Validation: Context
- FDA Guidance on Testing and Labeling Medical Devices for Safety in the Magnetic Resonance Environment: Labeling
- FDA Guidance on Remanufacturing Medical Devices: Defining the Scope
- FDA Guidance on Design Control: Design History File
- FDA on Medical Device Cybersecurity Risk Management
- FDA Guidance on Software Contained in Medical Devices: Additional Aspects
- FDA Guidance on Design Control: Design Transfer and Design Changes
- FDA Guidance on BCI Devices: Clinical Performance Testing
- FDA Guidance on Reprocessing Medical Devices: Validation and FDA Review
- FDA on BCI Devices: Animal Testing
- FDA on Acceptance Review for De Novo Requests: the Checklist
- FDA Guidance on Acceptance Review for De Novo Classification Requests
- FDA Guidance on De Novo Framework: Review Process
- FDA Guidance on De Novo Process: Submissions
- FDA Guidance on De Novo Classification Process
- FDA Guidance on Infusion Pumps: Specific Aspects
- FDA Guidance on eSubmission – Current Template
- FDA Draft Guidance on Electronic Submission Template for Medical Device 510(k) Submissions
- FDA Guidance on Reprocessing Medical Devices: Validation of Cleaning
- FDA Guidance on Design Validation
- FDA Guidance on Infusion Pumps: Performance Testing
- FDA Guidance on Postmarket Management of Cybersecurity in Medical Devices: Definitions and General Principles
- FDA Guidance on Infusion Pumps: Hazard Analysis
- FDA Guidance on Design Control: Design Verification
- FDA Guidance on Reprocessing Medical Devices: Criterion 4 – 5 for Reprocessing Instructions
- FDA on Content of Premarket Submissions For Medical Device Software: Documents in Detail
- FDA Draft Guidance on Denture Base Resins
- FDA Guidance on Infusion Pumps: Safety Assurance Cases
- FDA Guidance on Design Control: Design Review
- FDA Guidance on Software Changes: Examples
- FDA Guidance on Mandatory Device Recalls and Corrections
- FDA Guidance on BCI Devices: Non-Clinical Bench Testing
- FDA Guidance on Reprocessing Medical Devices: Criteria 1-3 for Reprocessing Instructions
- FDA Guidance on Medical Device Reporting: Specific Issues
- FDA Guidance on Premarket Submissions for Software Contained in Medical Devices: Documentation
- FDA Guidance on Software Validation: Terminology
- FDA Guidance on Medical Device Reporting: Written Procedures, Record-keeping and Public Disclosure
- FDA Guidance on Recalls: Additional Aspects
- FDA Guidance on Design Control: Design Output
- FDA Guidance on Regulatory Requirements for Device Software Functions
- FDA Guidance on Infusion Pumps: Device Description
- FDA Guidance on Development of Medical Device Labeling
- FDA on Medical Device Reporting: Specific Aspects
- FDA Guidance on BCI Devices: Specific Aspects
- FDA on Labeling For Radiation-Emitting Devices and Light-Emitting Products
- FDA Issues Final Rule Regarding “Intended Use”
- FDA Guidance on Good Manufacturing Practice Labeling Requirements
- FDA on MDR: Manufacturer’s Reporting Requirements in Detail
- FDA on Early Collaboration Meetings: Determination Meetings
- FDA Guidance on Recall Strategy: Development and Execution
- FDA Guidance on Design Control: Design Input
- FDA on Software Changes: Additional Factors
- FDA Policy on Software Functions
- FDA Guidance on Labeling for In Vitro Diagnostic Devices
- FDA Guidance on Manufacturer Reporting Requirements: Awareness and Submission
- FDA on Reusable Medical Devices and Reprocessing
- FDA on Implanted Brain-Computer Interface Devices: Software and Human Factor
- FDA Guidance on Infusion Pumps: Overview
- FDA Guidance on General Device Labeling
- FDA on Electronic Source Data in Clinical Investigations
- FDA Guidance on Recalls and Enhancements
- FDA Guidance on Recalls
- FDA on Postmarket Management of Cybersecurity in Medical Devices
- FDA Guidance on Design Control Basics
- FDA on Cybersecurity Practices for Servicing Medical Devices
- FDA Guidance on Unique Device Identification System
- FDA Guidance on Requests for Information
- FDA on General Principles of Labeling for Medical Devices
- FDA on Manufacturer Reporting Requirements
- FDA Guidance on Reprocessing Medical Devices in Health Care Settings
- FDA Guidance on Early Collaboration Meetings
- FDA Guidance on Electronic Medical Device Reporting (eMDR)
- FDA Safety Communication on Flexible Bronchoscopes
- FDA Guidance on Medical Device Data Systems and Image Devices
- FDA on Mobile Medical Applications: Basics
- FDA on General Principles of Software Validation
- FDA: How to Tell When a Software Change Requires a New 510(K)
- FDA Draft Guidance on Remanufacturing of Medical Devices
- FDA Guidance on Assessment of Radiofrequency-Induced Heating
- FDA on Cybersecurity for Networked Medical Devices Containing OTS Software
- FDA Guidance on Off-The-Shelf Software Use in Medical Devices
- FDA Premarket Submissions for Software Contained in Medical Devices
- FDA on Cybersecurity-related Content of Premarket Submissions
- FDA Guidance on Magnetic Resonance Diagnostic Devices
- FDA Guidance on Reporting of Computational Modeling Studies
- FDA Guidance on Premarket and Postmarket Data Collection
- FDA Guidance on Post-Approval Studies
- FDA on Postmarket Surveillance Under Section 522 of the FD&C Act
- FDA on Investigational Device Exemptions for Early Feasibility Studies
- FDA Guidance on Non-Clinical Bench Performance Testing Information
- FDA Guidance on 510(k) for Software Changes
- FDA Guidance on Feasibility and Early Feasibility Clinical Studies
- FDA Guidance on Implanted Brain-Computer Interface Devices
- FDA Guidance on Testing and Labelling Medical Devices for Safety in the Magnetic Resonance Environment
- FDA Guidance on 510(k) for Changes to Existing Devices
- FDA on Evaluation of Automated Endoscope Reprocessors
- FDA eSTAR Pilot Program
- FDA Medical Device Classification Update
- FDA Guidance on Acceptance and Filing Reviews for PMAs
- FDA Notice on Regulatory Flexibilities and Exemptions
- FDA on 510(k) Acceptability Criteria
- FDA Guidance on Preparing a Pre-Request for Designation
- FDA Guidance on Writing a Request for Designation
- FDA Guidance on Types of Communication
- FDA Guidance on eCopy Program for Medical Device Submissions
- FDA Guidance on Benefit-Risk Factors in Premarket Notifications (510(k))
- FDA on Significant and Nonsignificant Risk Medical Device Studies
- FDA Guidance on Q-Submission Program
- FDA Policy on Viral Mutations and COVID-19 Tests
- FDA Guidance on Patient-Reported Outcome Measures
- FDA Guidance on Intravascular Stents and Associated Delivery Systems
- CDRH on the Patient Science and Engagement Program
- FDA Breakthrough Devices Program: Request, Review, and Features
- FDA Guidance on Safer Technologies Program for Medical Devices
- FDA on Mouse Embryo Assay for Assisted Reproduction Technology Devices
- FDA Breakthrough Devices Program: General Overview
- FDA Guidance on Coagulation Systems for Measurement of Viscoelastic Properties
- FDA Action Plan for AI/ML-Based SaMD
- FDA Guidance on MDSAP Audit Approach
- FDA on Product Labeling for Laparoscopic Power Morcellators
- FDA Criteria for Spinal Plating Systems and Orthopedic Non-Spinal Metallic Bone Screws and Washers
- FDA Virtual Town Hall on COVID-19 Tests
- FDA Proposed Framework for Modifications to AI/ML-Based SaMD
- FDA on Requesting Feedback on Combination Products
- FDA Enforcement Policy for Bioburden Reduction Systems
- FDA on Radio Frequency Wireless Technology in Medical Devices
- FDA on Benefit-Risk Factors for Medical Devices: Key Points
- FDA Guidance on Electromagnetic Compatibility
- FDA Guidance on Certificates of Confidentiality
- FDA Guidance of Micro-Needling Products
- FDA: Requesting a Review of Decision Not to Issue an Export Certificate
- FDA on Exporting Medical Devices
- FDA ASCA Pilot Program in Detail: Development and Roles
- FDA Revised Policy for Remote Monitoring Devices
- FDA: Recognition and Withdrawal of Voluntary Consensus Standards
- FDA Communication Paper on Cybersecurity Vulnerabilities
- FDA Guidance on Medical Devices Containing Nitinol
- FDA Draft Guidance on Biocompatibility of Certain Devices
- FDA Policy for Modifications to Molecular Influenza and RSV Tests
- FDA: Blood Glucose Monitoring Systems for Prescription Point-of-Care Use
- FDA on Biocompatibility Testing of Devices Under ASCA Pilot
- FDA Guidance on Self-Monitoring Blood Glucose Test Systems
- FDA: Basic Safety and Essential Performance of Medical Electrical Equipment
- Taiwan Technical Guidelines on Medical Device Software
- FDA: Accreditation Scheme for Conformity Assessment Pilot Program
- FDA Medical Software Pre-Cert Pilot Program
- FDA Improves the Electronic Medical Device Reporting System
- FDA Guidance on International Standard ISO 10993-1
- FDA: Annual Reports for Approved PMA
- FDA Voluntary Consensus Standards
- FDA: Patient-Reported Outcome Instruments for Use in Evaluation
- FDA to Reclassify Non-Invasive Bone Growth Stimulators
- FDA Guidance on Cutaneous Electrodes for Recording Purposes
- FDA Guidance on the Safety and Performance Based Pathway
- FDA FAQ on Importing, Registration and Listing Medical Devices
- FDA Pilot Program for RFD and Pre-RFD Electronic Submissions
- FDA Amends Medical Device User Fees
- FDA Exemption for Class II Medical Devices
- FDA Guidance on Clinical Investigations for Prostate Tissue Ablation Devices
- FDA Guidance on Electronic 745A(b) Submissions for Medical Devices
- FDA Guidance on BHP Treatment Medical Devices
- SFDA: Listing and Marketing Authorization Requirements
- FDA Policy on Unique Device Identification
- FDA Guidance on Medical Device Establishment Inspections
- FDA Approves First Medical Device Development Tools
- EC Guidelines on Manufacturer Incident Report Form
- FDA Template for Home Collection Kits
- FDA Guidance on Supplements for PMA and HDE Submissions
- Infusion Pumps: FDA Emergency Use Authorization
- FDA: Final Guidance on 3P510K
- CDRH Guidance: Permanent Discontinuance or Interruption
- FDA Umbrella EUA for SARS-CoV-2 Antibody Tests
- FDA Guidance on Remote Digital Pathology Devices
- FDA Enforcement Policy for Telethermographic Systems
- FDA Guidance on Digital Health Devices
- FDA Enforcement Policy for Infusion Pumps and Thermometers
- FDA Guidance on Ventilators and Accessories
- FDA Policy on Remote Auditing Pilot Program
- Monitoring Devices: A New FDA Policy
- FDA Guidance on Clinical Trials During COVID-19 Pandemic