Final 529
- Q-Submission Program: Strategic Framework for FDA Interactions in Medical Device Development
- Evaluation of Sex-Specific Data in Medical Device Clinical Studies
- Written Procedures for Institutional Review Boards (IRBs): Content and Organization
- Modular Submissions for Premarket Approval Applications and Humanitarian Device Exemptions
- Notifying Device Supply Disruptions and Manufacturing Discontinuances During Public Health Emergencies
- Global Unique Device Identification Database (GUDID) Data Submission and Management Requirements
- Predetermined Change Control Plans for Artificial Intelligence and Machine Learning-Enabled Device Software Functions
- Ethylene Oxide Sterilization Facility Changes for Class III Medical Devices During EPA Emissions Standards Transition
- Technical Considerations for Non-Spinal Metallic and Polymer Bone Plates and Screws
- Class II Non-Spinal Metallic Bone Screws and Washers - Safety and Performance Based Pathway
- Third Party Review Program for Medical Device 510k and Emergency Use Authorization Reviews
- Long-Term Neurodevelopmental Safety Evaluation of Medical Products Used in Neonates
- Testing and Labeling Requirements for Titanium Alloy Dental Implants and Abutments
- Technical Performance Testing for Dental Cements and Resin-Modified Materials
- Technical Considerations for Dental Ceramics Used in Artificial Teeth and Restorations
- Dental Impression Materials: Performance Criteria and Testing Requirements
- Air-Powered Dental Handpieces and Motors - Performance Testing and Safety Requirements
- X-Ray Equipment Performance Standards and Radiation Safety Requirements
- Appeals Process for Mammography Facilities under MQSA: Adverse Accreditation Decisions, Certificate Actions, and Patient Notifications
- Voluntary Malfunction Summary Reporting Program for Medical Devices
- Mammography Quality Standards: Requirements for Facilities, Personnel, Equipment, and Reporting
- Electronic Submission Template And Resource (eSTAR) for De Novo Classification Requests
- Device Classification and Regulatory Requirements: Procedures for 513(g) Requests for Information
- Electronic Submission of User Manuals and Radiation Safety Reports for Electronic Products
- User Fees for Combination Products and Associated Waivers
- Clinical Study Design Recommendations for Devices to Treat Opioid Use Disorder
- Laboratory Developed Tests (LDTs) Enforcement Discretion Policy and Phased Compliance Requirements
- Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection
- Distinguishing Between Medical Device Servicing and Remanufacturing Activities
- Submission Requirements for Terminally Sterilized Medical Devices
- Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions
- Review Process for Denied Export Certificates for Medical Devices
- Clinical Electronic Thermometers - Performance, Safety, and Regulatory Requirements
- Manufacturing and Supply Chain Changes for PMA and HDE Devices During Public Health Emergency
- Modifications to Non-Invasive Remote Monitoring Devices for Patient Monitoring During Public Health Emergencies
- Testing and Labeling of Medical Devices for Magnetic Resonance (MR) Environment Safety and Compatibility
- Premarket Notification Requirements for Magnetic Resonance Diagnostic Devices
- Electronic Submission Template And Resource (eSTAR) for 510k Submissions
- Technical Considerations for Physiologic Closed-Loop Control Medical Devices
- Predetermined Change Control Plans for Antimicrobial Susceptibility Test Systems: Updating Breakpoints in Device Labeling
- Cybersecurity in Medical Devices: Design, Implementation, and Premarket Submissions
- Voluntary Improvement Program (VIP) for Medical Device Manufacturers: Participation Requirements and Implementation
- Breakthrough Devices Program: Expedited Development and Review Process for Novel Medical Devices
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Human Factors Studies and Related Analyses for Combination Products
- Face Masks and Barrier Face Coverings for Medical Purposes During the COVID-19 Public Health Emergency
- Informed Consent in Clinical Investigations: Requirements, Documentation, and Procedures
- Off-The-Shelf Software in Medical Devices: Documentation Requirements for Premarket Submissions
- Labeling Recommendations for Hydrogen Peroxide-Based Contact Lens Care Products
- Medical Device Development Tools (MDDT) Qualification Program
- Content of Premarket Submissions for Device Software Functions
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
- Testing of Tissue Containment Systems Used During Power Morcellation Procedures
- Use of Whole Slide Imaging in GLP Nonclinical Toxicology Studies
- Testing Considerations for Percutaneous Transluminal Angioplasty (PTA) and Specialty Balloon Catheters
- Risk-Based Monitoring of Clinical Investigations
- Testing and Performance Requirements for Soft Daily Wear Contact Lenses
- Animal Testing for Medical Device Safety and Performance Evaluation
- Transition Plan for Medical Devices with COVID-19 Emergency Use Authorization After Declaration Termination
- Transition Plan for Medical Devices Distributed Under COVID-19 Emergency Enforcement Policies
- Ultrasonic Diathermy (Physiotherapy) Devices - Technical and Safety Requirements for 510k Submissions
- Performance Standards for Diagnostic X-Ray Systems and Major Components
- Marketing Clearance Requirements for Diagnostic Ultrasound Systems and Transducers
- Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 Standards
- Harmonization of Performance Standards for Diagnostic X-Ray Imaging Systems and Components with IEC Standards
- Assembly and Installation Requirements for Diagnostic X-ray Equipment and Components
- Impact of Viral Mutations on SARS-CoV-2 Tests: Evaluation and Monitoring Recommendations
- COVID-19 Testing Policy: Validation Requirements and Recommendations for Diagnostic and Serology Tests
- Clinical Investigator Disqualification Procedures and Administrative Actions
- References to Section 201(h) of the FD&C Act Following the Safeguarding Therapeutics Act
- Developing and Responding to Medical Device Marketing Application Deficiencies
- Postmarket Surveillance Studies Requirements for Medical Devices Under Section 522
- Post-Approval Studies for Medical Devices: Protocol Development, Tracking and Reporting Requirements
- User Fees and Refunds for Premarket Approval Applications and Biologics License Applications
- User Fees and Refunds for 510k Submissions
- User Fee Requirements and Payment Process for 513(g) Requests for Information
- De Novo Classification Request User Fees and Refund Policies
- MDUFA Performance Goals and Processing of 510k Submissions
- FDA Actions on Premarket Approval Applications (PMAs) and Effects on MDUFA Review Goals and Timelines
- De Novo Classification Request Review Process and Performance Goals
- Technical Performance Assessment and Premarket Requirements for Digital Diagnostic Radiology Display Devices
- Policy for Device Software Functions and Mobile Medical Applications
- Medical Device Data Systems, Medical Image Storage, and Medical Image Communications Devices - Policy for Functionality and Regulatory Status
- Computer-Assisted Detection Devices in Radiology: Performance Testing, Documentation and Labeling Requirements
- Clinical Performance Assessment of Computer-Assisted Detection Devices in Radiology
- Clinical Decision Support Software Functions: Device vs Non-Device Classification
- Policy for Monkeypox Testing During the Public Health Emergency
- Regulatory Requirements for Hearing Aids and Personal Sound Amplification Products (PSAPs)
- Applying Previously Cleared IVD Assays to Additional Automated Laboratory Instruments
- Unique Device Identification Policy for Class I and Unclassified Devices: Compliance Dates and Requirements
- Technical Performance Assessment of Quantitative Imaging in Radiological Devices
- Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
- Clinical Studies for Medical Devices Treating Type 2 Diabetes Through Novel Therapeutic Approaches
- Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
- Testing and Safety Requirements for Denture Base Resins
- Facet Screw Systems - Safety and Performance Based Pathway
- Testing and Performance Requirements for Surgical Sutures
- Non-Spinal Metallic Fracture Fixation Plates - Safety and Performance Based Testing Requirements
- Compliance Requirements for Ophthalmic Drug-Device Combination Products Following Genus Decision
- Procedures for Supervisory Review, Appeals, and Dispute Resolution for Medical Device Decisions
- Including Older Adults in Cancer Clinical Trials: Design and Conduct Considerations
- Premarket Review Pathways for Combination Products
- Patient Engagement in Medical Device Clinical Studies: Roles, Benefits and Best Practices
- Patient-Reported Outcome Instruments in Medical Device Evaluation
- Histopathology Peer Review in Nonclinical Toxicology Studies
- Clinical and Non-Clinical Testing for Medical Devices to Treat Benign Prostatic Hyperplasia (BPH)
- Multiple Patient Use Arthroscopy Pump Tubing Sets - Safety, Testing and Labeling Requirements
- Labeling Requirements for Surgical Staplers and Staples for Internal Use
- De Novo Classification Process for Novel Medical Devices Without Predicates
- Acceptance Review for De Novo Classification Requests
- Export Certification Process and Requirements for FDA-Regulated Products
- Technical Considerations for Nitinol-Containing Medical Devices
- Unique Device Identifier (UDI) Form and Content Requirements
- Peripheral Vascular Atherectomy Devices - Content and Testing Requirements for 510k Submissions
- Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation - Technical Considerations for Q-Submissions and IDE Applications
- Safer Technologies Program for Medical Devices and Device-Led Combination Products with Enhanced Safety Benefits
- Mouse Embryo Assay Testing for Assisted Reproduction Technology Devices
- Product Labeling Requirements for Laparoscopic Power Morcellators in Gynecologic Surgery
- Testing and Performance Requirements for MR Receive-Only Coils for General Diagnostic Use
- Spinal Plating Systems - Safety and Performance Based Testing for Anterior Cervical and Anterior/Lateral Thoracolumbar Devices
- Obtaining FDA Feedback for Combination Products: Best Practices and Meeting Procedures
- Certificates of Confidentiality for Non-Federally Funded Research: Protection of Human Subject Privacy in FDA-Regulated Studies
- Regulatory Considerations for Microneedling Devices Used in Aesthetic Skin Treatments
- Testing for Biotin Interference in In Vitro Diagnostic Devices Using Biotin/Avidin Technology
- Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Home Use
- Breast Implants - Premarket Requirements for Saline and Silicone Gel-Filled Devices
- Breast Implant Labeling: Patient Communication and Risk Information Requirements
- Blood Glucose Monitoring Systems for Prescription Point-of-Care Use - Performance Standards and Technical Requirements
- Biological Evaluation of Medical Devices Standards in the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
- Basic Safety and Essential Performance Standards for Medical Electrical Equipment Under the ASCA Pilot Program
- Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program for Medical Device Testing Laboratories
- Recognition and Withdrawal Process for Voluntary Consensus Standards
- Performance Testing and Safety Requirements for Single-Use Cutaneous Recording Electrodes
- Conventional Foley Urinary Catheters - Performance Testing and Labeling Requirements
- Civil Money Penalties Related to ClinicalTrials.gov Requirements
- Multiple Function Device Products: Policy and Considerations for Functions Not Subject to FDA Review
- Electronic Submission Requirements for Medical Device Submissions
- Clinical Investigation Requirements for Prostate Tissue Ablation Systems
- Uniform Inspection Process and Communications for Medical Device Establishments
- Classification and Special Controls for Posterior Cervical Screw Systems
- Electronic Copy (eCopy) Program for Medical Device Submissions: Technical Standards and Requirements
- Requesting Nonbinding Feedback on Form FDA 483 Inspectional Observations
- Developing and Labeling Companion Diagnostics for Multiple Oncology Therapeutic Products
- Appeals Process and Documentation Requirements for Significant Medical Device Submission Decisions
- Testing and Performance Requirements for Electrosurgical Devices and Accessories for General Tissue Cutting and Coagulation
- Bone Anchors (Suture Anchors) for Appendicular Skeleton - Content and Testing Requirements for 510k Submissions
- Product Recalls, Removals, and Corrections: Procedures and Best Practices
- Dual 510k and CLIA Waiver by Application for In Vitro Diagnostic Tests
- CLIA Waiver Applications for In Vitro Diagnostic Devices - Demonstrating Simplicity and Insignificant Risk of Erroneous Results
- Recommended Format and Content for Non-Clinical Bench Performance Testing in Medical Device Premarket Submissions
- Real-Time Review Process for Minor Changes to Approved Medical Devices through PMA Supplements
- Annual Reports for PMA-Approved Medical Devices: Content, Format and Submission Requirements
- Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)
- 30-Day Notice Manufacturing Changes for PMA and HDE Approved Devices
- Labeling for Intravascular Devices with Lubricious Coatings
- Coronary, Peripheral, and Neurovascular Guidewires - Performance Testing and Documentation Requirements
- General Wellness Products: Policy for Low Risk Devices and Software Functions
- Changes to Medical Device Definition for Software Functions Under the 21st Century Cures Act
- Safety and Performance Based Pathway for 510k Substantial Equivalence Demonstration
- The Abbreviated 510k Program: Using Guidance Documents, Special Controls, and Standards for Substantial Equivalence Demonstration
- Special 510k Program for Device Modifications: Eligibility Criteria and Submission Requirements
- Humanitarian Device Exemption (HDE) Program: Operational Requirements and Benefit-Risk Assessment
- Humanitarian Use Device (HUD) Designation Requests: Content and Format
- Benefit-Risk Determinations for Medical Device Premarket Review
- Benefit-Risk Assessment with Uncertainty in Medical Device Premarket Submissions
- Metal Expandable Biliary Stents and Associated Delivery Systems - Content and Testing Requirements for 510k Submissions
- Postmarketing Safety Reporting Requirements for Combination Products
- Technical Specifications for Next Generation Sequencing Data in Antiviral Drug Development
- Live Case Presentations During Investigational Device Clinical Trials
- Performance Standard Requirements for Fluoroscopic X-Ray Systems: Timing, Safety Features and Display Requirements
- Non-Clinical Testing Recommendations for Machine Perfusion Devices Used to Preserve Vascularized Human Organs for Transplant
- Laser Illuminated Projectors (LIPs) - Classification, Safety Requirements and Labeling
- Unique Device Identification Requirements for Convenience Kits
- Testing and Characterization of Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices
- Compliance Policy for Combination Product Postmarketing Safety Reporting Requirements
- Medical Devices Containing Animal-Derived Materials - Safety and Risk Management Requirements
- Release of Laboratory Test Results to Responsible Parties Without Freedom of Information Act Requests
- Medical Devices Used in Recovery, Isolation, and Delivery of Regenerative Medicine Advanced Therapies
- Public Warning and Notification of Recalls Under Part 7
- 510k Exemption for Unclassified Medical Devices in Selected Product Categories
- Least Burdensome Principles for Medical Device Regulation
- Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices
- Manufacturing Site Changes for PMA-Approved Medical Devices: When to Submit a Supplement and Documentation Requirements
- Impact of Revised Common Rule on FDA-Regulated Clinical Investigations
- Selection of Package Type Terms and Discard Statements for Injectable Medical Products
- Benefit-Risk Factors to Consider When Evaluating Substantial Equivalence in 510k Submissions
- Heparin in Medical Devices and Combination Products: Testing, Labeling and Safety Requirements
- Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices
- Medical Device User Fee Small Business Qualification and Certification Process
- Distribution of LOINC Codes for In Vitro Diagnostic Tests by Manufacturers
- Medical Product Communications That Are Consistent With FDA-Required Labeling
- Health Care Economic Information Communications to Payors for Medical Devices
- Use of Next Generation Sequencing in the Diagnosis of Germline Diseases
- Use of Genetic Variant Databases as Sources of Valid Scientific Evidence for Clinical Validity of Genetic Tests
- Acceptance of Clinical Data to Support Medical Device Applications and Submissions
- How to Submit a Pre-Request for Designation (Pre-RFD) for Product Classification and Center Assignment
- Medical Device Accessories: Classification and Risk-Based Approach
- Clinical Evaluation of Software as a Medical Device (SaMD)
- Technical Considerations for Additive Manufactured Medical Devices
- IDE Device Categorization for Medicare Coverage: Category A vs Category B Determination
- Pediatric X-Ray Imaging Device Premarket Submissions: Design, Testing, and Labeling Considerations
- Direct Marking of Devices with Unique Device Identification (UDI) Requirements for Reusable Medical Devices
- Sharing Patient-Specific Information from Medical Devices with Patients
- Labeling Requirements for Ultrasonic Surgical Aspirator Devices - Contraindication for Uterine Fibroid Procedures
- Deciding When to Submit a New 510k for Software Changes to Medical Devices
- Deciding When to Submit a New 510k for Changes to an Existing Medical Device
- Administrative Procedures for CLIA Categorization of In Vitro Diagnostic Tests
- Minutes of Institutional Review Board (IRB) Meetings - Content and Documentation Requirements
- Classification of Products as Drugs or Devices: Interpretation and Determination Process
- Establishing Performance Characteristics for Human Papillomavirus (HPV) Detection In Vitro Diagnostic Devices
- Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies
- Design Considerations and Recommendations for Interoperable Medical Devices
- Procedures for Medical Devices Advisory Committee Panel Meetings
- Use of Real-World Data to Generate Evidence for Medical Device Regulatory Decisions
- Certifying Compliance with Clinical Trial Registration Requirements on Form FDA 3674
- Emergency Use Authorization of Medical Products: Requirements and Procedures for Unapproved Products and Uses
- Benefit-Risk Factors in IDE Applications for Medical Device Clinical Investigations
- Current Good Manufacturing Practice Requirements for Combination Products
- Postmarket Management of Cybersecurity in Medical Devices
- Benefit-Risk Factors in Medical Device Product Availability, Compliance, and Enforcement Decisions
- Use of Electronic Informed Consent in Clinical Investigations
- Public Notification of Medical Device Emerging Signals: New Safety Information and Adverse Events
- Mitigating Cross-Contamination Risks in Irrigation Valves and Accessories Used with Flexible Gastrointestinal Endoscopes
- Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers
- Clinical Trial Considerations for Neurological Devices Intended to Slow, Stop, or Reverse Disease Progression
- Labeling Requirements for Permanent Hysteroscopic Tubal Implants for Female Sterilization
- Collection and Reporting of Race and Ethnicity Data in Clinical Trials
- Reporting of Computational Modeling and Simulation Studies in Medical Device Submissions
- Solid State X-ray Imaging Devices for Medical Diagnostic Use
- Patient Preference Information in Medical Device Development, Clinical Trials, and Regulatory Decision Making
- Bipolar Electrosurgical Vessel Sealers for General Surgery - Performance Testing and Labeling Requirements
- Adaptive Designs for Medical Device Clinical Studies
- Leveraging Existing Clinical Data for Pediatric Medical Device Indications
- Technical Performance Assessment of Digital Whole Slide Imaging Systems in Anatomic Pathology
- Radiation Biodosimetry Devices: Performance Testing and Documentation Requirements
- Assessment of Radiofrequency-Induced Heating in Multi-Configuration Passive Medical Devices for MR Conditional Labeling
- Clinical Trial Design and Regulatory Considerations for Nail Appearance and Onychomycosis Treatment Devices
- Assay Development and Validation Requirements for Lamotrigine and Zonisamide Testing in Clinical Laboratories
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Special Controls for Implanted Blood Access Devices for Hemodialysis
- Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices - Testing and Clinical Requirements
- Premarket Regulatory Requirements for Liquid Barrier Protection Claims in Medical Gowns
- Corrosion Testing and Surface Characterization Requirements for Intravascular Stents
- Endotoxin Testing for Single-Use Intraocular Ophthalmic Devices
- Meetings with the Office of Orphan Products Development: Procedures and Best Practices
- Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization Test Systems for Bone Marrow Specimens
- Balancing Pre-Market and Post-Market Data Collection for PMA Medical Devices
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
- Safety and Performance of Enteral Device Connectors to Reduce Misconnection Risks
- Safety of Children's Toy Laser Products
- Recommendations for Labeling Medical Products Without Natural Rubber Latex
- Infusion Pumps - Total Product Life Cycle Recommendations for Safety and Performance
- Design Considerations for Medical Devices Intended for Home Use
- Dual Use Molecular Diagnostic Instruments with FDA-Approved and Non-Approved Functions
- Distinguishing Between Medical Device Recalls and Device Enhancements
- Custom Device Exemption Requirements and Implementation
- Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices
- Unique Device Identification System: Implementation and Compliance Requirements
- IDE Clinical Investigation Decision Process and Requirements
- In Vitro Companion Diagnostic Devices: Development, Review Process, and Labeling Requirements
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
- Considering Whether FDA-Regulated Products Involve Nanotechnology
- Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices
- Transfer of Clinical Investigation Oversight Between Institutional Review Boards
- Providing Pediatric Use Information for Medical Device Premarket Submissions Under Section 515A
- Types of Communication During Medical Device Submissions Review
- Same-Sex Marriage Recognition in Regulatory Definitions of Spouse and Family
- Medical Device Tracking Requirements and Implementation Procedures
- Premarket Assessment of Medical Devices for Pediatric Use
- Public Disclosure of Advisory Committee Members' Financial Interests and Waivers
- Electronic Medical Device Reporting: Questions and Answers on Electronic Submission of Postmarket Reports
- Research Use Only and Investigational Use Only In Vitro Diagnostic Products - Labeling and Distribution Requirements
- Design Considerations for Medical Device Pivotal Clinical Studies
- Early Feasibility Medical Device Clinical Studies Including First in Human (FIH) Studies
- Electronic Source Data in Clinical Investigations
- IRB Responsibilities for Reviewing Investigator Qualifications, Research Sites, and IND/IDE Requirements
- Radio Frequency Wireless Technology in Medical Devices
- Risk-Based Monitoring in Clinical Investigations of Medical Products
- Technical Considerations for Pen, Jet, and Related Injectors Submitted in Drug and Biological Product Applications
- Public Participation in Open Public Hearing Sessions of Advisory Committee Meetings
- Migration Studies for In Vitro Diagnostic Devices Moving to New Systems
- Medical Device Product Code Usage and Requirements
- Exception from Informed Consent Requirements for Emergency Research
- In Vitro Diagnostic Devices for Detection of Antibodies to Borrelia burgdorferi - Performance Characteristics and Testing Requirements
- Retinal Prostheses: Clinical, Non-Clinical, and Safety Recommendations for Electrical Stimulation Devices
- Pulse Oximeters - Performance Testing and Safety Requirements for SpO2 and Pulse Rate Measurement Devices
- Clinical Study Design for Surgical Ablation Devices Used in Treatment of Atrial Fibrillation Under Direct Visualization
- Financial Disclosure Requirements for Clinical Investigators
- The Content and Development of Premarket Submissions for Artificial Pancreas Device Systems
- Continuing Review of Clinical Investigations by Institutional Review Boards (IRBs)
- In Vitro Diagnostic Devices for Detection and Differentiation of Influenza Viruses - Performance Testing and Validation Requirements
- How to Submit a Request for Designation (RFD) for Product Classification and FDA Center Assignment
- Clinical Investigation of Medical Devices for Treatment of Urinary Incontinence
- Blood Lancets - Single Patient Use Only Labeling Requirements
- Including Manufacturer's URL on Electronic Product Labels
- Impact-Resistant Lenses in Eyeglasses and Sunglasses: Testing, Documentation, and Import Requirements
- Contact Lens Care Product Labeling: Warnings, Instructions and Readability Requirements
- In Vitro Diagnostic Device Studies Exempt from Investigational Device Exemption Requirements
- Non-Clinical Testing and Labeling Requirements for Extracranial Intravascular Stents and Delivery Systems
- Bayesian Statistics in Medical Device Clinical Trials
- Bayesian Statistics in Medical Device Clinical Trials: Design, Analysis and Implementation
- Adding Imaging Contrast Indications to Medical Devices Used with Approved Imaging Drugs
- Patient-Reported Outcome Measures: Development, Implementation and Evaluation in Clinical Trials
- Investigator Responsibilities - Protecting Human Subjects and Ensuring Data Integrity in Clinical Research
- IRB Registration Requirements and Procedures
- Color Additive Petitions: Chemical and Technical Requirements for Food, Drugs, Cosmetics, and Medical Devices
- Adverse Event Reporting to IRBs Under FDA-Regulated Research
- Safety Considerations for Hand-Held X-Ray Equipment: Radiation Protection and Testing Requirements
- Modifications to PMA-Approved Class III Medical Devices: Selecting the Appropriate Regulatory Submission Type
- Data Retention Requirements When Clinical Trial Subjects Withdraw from FDA-Regulated Studies
- Clinical Study Design Recommendations for Catheter Ablation Devices in Treatment of Type I Atrial Flutter
- Voting Procedures for Advisory Committee Meetings
- Preparation and Submission of Advisory Committee Briefing Materials for Public Release
- Intravascular Administration Sets and Accessories - Testing and Documentation Requirements
- Import Surveillance and Detention of Medical Gloves that Fail Water Leak Testing
- Import Surveillance and Detention Process for Condoms Failing Water Leak Testing Requirements
- Hemodialysis Blood Tubing Sets - Performance, Testing, and Labeling Requirements
- Clinical Investigation of Nocturnal Home Hemodialysis Delivery Systems
- Total Artificial Disc Devices - Pre-clinical Testing and Clinical Trial Design Requirements
- Container and Closure System Integrity Testing as an Alternative to Sterility Testing for Stability Protocols
- Coronary and Carotid Embolic Protection Devices - Performance Testing and Labeling Requirements
- Medical Gloves - Premarket Notification, Quality System, Labeling and Compliance Requirements
- Manufacturing Site Inspections and PMA Review Process for Medical Devices
- Inspection and Field Testing Requirements for Sunlamp Products and UV-Emitting Devices
- Inspection and Field Testing Requirements for Radiation-Emitting Electronic Products
- Biological Indicators for Healthcare Facility Sterilization Process Monitoring - 510k Submission Requirements
- Laser Light Show Variance Renewal and Amendment Procedures
- Safety and Performance Requirements for Cabinet X-ray Security Screening and Industrial Quality Control Systems
- Non-Clinical Testing and Labeling Requirements for Femoral Stem Prostheses in Hip Replacement Systems
- Marketing and Distribution Requirements for Analyte Specific Reagents (ASRs)
- Dear Doctor Letters for Implantable Cardioverter Defibrillator Recalls: Content and Format Recommendations
- Jurisdictional Determinations for HCT/P Processing Devices: CBER vs CDRH Assignment
- Bundling Multiple Devices and Multiple Indications in Medical Device Submissions
- Neurothrombectomy Devices for Acute Ischemic Stroke Treatment - Pre-clinical and Clinical Testing
- Dental Handpieces - Performance Testing, Safety Requirements and Labeling
- Alternative Labeling Methods for Laser Products
- Statistical Guidance for Reporting Diagnostic Test Results with Qualitative Outcomes
- Process for Clinical Investigations Involving Children Requiring Additional Safeguards
- Regulatory Requirements for Decorative Non-Corrective Contact Lenses
- Keratomes and Replacement Keratome Blades for Corneal Surgery
- Early Development Considerations for Combination Products
- Reprocessor Identification Requirements for Reprocessed Single-Use Devices
- Color Additives in Contact Lenses: Preparing and Submitting Petitions
- Use of Leftover Human Specimens in IVD Device Studies: Requirements for IDE Exemption and Privacy Protection
- Establishment and Operation of Clinical Trial Data Monitoring Committees
- Tonometers for Measuring Intraocular Pressure - Testing and Performance Requirements
- Dental Curing Lights - Performance Testing and Safety Requirements
- Hospital Bed System Dimensional and Safety Requirements to Reduce Patient Entrapment
- Electronic Distribution of Product Information and Safety Communications
- Pharmacogenetic Tests: Premarket Submission Requirements and Performance Validation
- Exemption from Reporting Requirements for Low Risk Class I Laser Products
- High-Intensity Mercury Vapor Discharge Lamps: Scope of Performance Standard and Requirements for General Purpose Lighting vs. Specialized Applications
- Premarket Notification Requirements for Dental Composite Resin Materials
- C-Reactive Protein (CRP) Assays - Premarket Notification 510k Submissions
- Medical Devices with Sharps Injury Prevention Features - Testing, Documentation and Labeling Requirements
- Menstrual Tampons and Menstrual Pads - Testing and Labeling Requirements for 510k Submissions
- Civil Penalties for Electronic Product Radiation Control Violations
- Pharmacogenomic Data Submissions in Drug Development and Biomarker Classification
- X-ray Tube Housing Assembly Reloading Facilities: Registration, Listing and Inspection Requirements
- Regulatory Requirements and Enforcement Actions for Defective Sunlamp Products Manufactured Before May 7, 1980
- Regulatory Actions and Civil Penalties for Non-Compliant Diagnostic X-ray Equipment Assemblers
- Cybersecurity for Networked Medical Devices with Off-The-Shelf Software
- Cybersecurity Maintenance for Medical Devices with Off-The-Shelf Software
- Clinical Data Presentation for Orthopedic Implant Device Submissions
- Clinical Studies for Vertebral Body Augmentation Devices in Treatment of Insufficiency Fractures
- Validation Data Requirements for Reprocessed Single-Use Medical Devices
- Dispute Resolution Process for Combination Product Review Timelines
- Spinal Plating Systems and Vertebral Body Replacement Devices - Content and Testing Requirements for 510k Submissions
- Performance Testing and Labeling Requirements for Surgical and Medical Face Masks
- Vocal Fold Medialization Devices - Testing and Documentation Requirements
- Chemical Indicators for Sterilization Process Monitoring in Healthcare Facilities - Content and Format Requirements for 510k Submissions
- Electronic Records and Electronic Signatures - Scope and Application
- Assembly, Installation, Adjustment and Testing Information Requirements for Diagnostic X-Ray Systems
- Registration and Listing Requirements for Single-Use Device Reprocessors and Hospitals
- Pediatric Expertise for Advisory Panels Reviewing Medical Device Submissions
- Quality System Information Requirements for Premarket Submissions
- Determining and Managing Off-Label Use Concerns in 510k Submissions
- Medical Device Reporting for Needlestick and Other Sharps Injuries
- Military Laser Products: Department of Defense Exemption Requirements and Compliance Process
- Resorbable Adhesion Barrier Devices for Abdominal and Pelvic Use - Development and Testing Requirements
- Software Validation for Medical Device Production, Quality Systems, and Device Components
- Sterilization of Convenience Kits: Component Compatibility and Validation Requirements
- Labeling Requirements for Reprocessed Single-Use Medical Devices
- Reprocessing of Single-Use Medical Devices: Requirements for Third-Party and Hospital Reprocessors
- Labeling Requirements for Keratomes Used in LASIK Surgery
- Changes to Investigational Device Exemption (IDE) Protocols and When FDA Approval is Required
- Laser Light Show Projectors - Variance Requirements and Safety Standards
- Writing Medical Device Patient Labeling: Content and Design Considerations
- Early Collaboration Meetings for Medical Device Development: Determination and Agreement Procedures
- Organ Preservation Solutions for Transplantation - Testing and Development Requirements
- Dura Substitute Devices - Premarket Notification (510k) Submissions
- Labeling for Electronic Anti-Theft Systems to Alert Implantable Medical Device Wearers
- Use of Data from Approved PMAs to Support New Device Approvals After 6 Years
- Content Considerations for Superficial and Interstitial Photon-Emitting Radionuclide Brachytherapy Sources
- Over-the-Counter Pregnancy Test Devices - 510k Submission Requirements and Performance Standards
- Consolidated Annual Reporting for Pacemaker Product Lines (1-CARD)
- Orthokeratology Rigid Gas Permeable Contact Lenses - Premarket Submissions and Clinical Testing Requirements
- ENT Endoscope Sheaths - Requirements for 510k Submissions
- Testing Requirements for Metallic Plasma Sprayed Coatings on Orthopedic Implants
- Premarket Requirements for Nitric Oxide Delivery Systems and Gas Analyzers
- Premarket Notification Requirements for Penile Rigidity Implants
- Preparation of IDE Applications for Spinal Systems: Pedicle Screws, Intervertebral Body Fusion, Vertebral Body Replacement, and Disc Replacement Devices
- Liquid Chemical Sterilants and High Level Disinfectants - Content and Format of 510k Submissions
- Inferior Vena Cava Filters - Testing and Labeling Requirements
- Powered Muscle Stimulator Premarket Notification 510k Submissions
- Clinical Study Design for Cardiac Ablation Systems in Treatment of Ventricular Tachycardia
- Immunological Testing for Medical Devices: Evaluation and Assessment of Adverse Effects
- Promotion and Recruitment for Investigational Medical Devices
- Keratoprostheses - Special Controls and Testing Requirements for 510k Submissions
- Preparation of 510k Submissions for General Surgical Meshes
- Premarket Notification Requirements for Dermabrasion Devices
- Labeling Claims for Natural Rubber Medical Devices with Reduced Potential for Chemical Sensitization
- Content Considerations for 510k Submissions of Emission Computed Tomography and Nuclear Tomography Systems
- Premarket Notification Requirements for Radionuclide Dose Calibrators
- Non-Automated Sphygmomanometers - Testing and Documentation Requirements
- Aqueous Shunts for Glaucoma Treatment - Testing and Documentation Requirements
- Categories of Research Eligible for Expedited IRB Review
- Documentation Requirements for Medical Devices Containing Animal-Derived Materials
- Premarket Notification Requirements for Cardiac Monitors, Heart Rate Meters, and Alarms
- Diagnostic Electrocardiograph Devices - Performance Testing and Safety Requirements
- General vs. Specific Indications for Use in Medical Device Substantial Equivalence Determinations
- Noise Claims in Labeling for Air Conduction Hearing Aids
- Nonprescription Sunglasses - Requirements for Class I Over-The-Counter Devices
- Powered Suction Pump 510k Submissions: Information Requirements and Testing Recommendations
- Premarket Notification Requirements for Over-The-Counter Denture Products and Repair Kits
- Accidental Radioactive Contamination of Human Food and Animal Feeds: Recommendations for State and Local Agencies
- Adding Lens Finishing Laboratories to Class III Rigid Gas Permeable Contact Lens PMAs
- Male Latex Condoms - Abbreviated 510k Submissions Using Consensus Standards
- Uniform Contraceptive Device Labeling for Pregnancy and STD Protection Information
- AC-Powered Slit Lamp Biomicroscopes - Requirements for 510k Submissions
- Regulatory Requirements for Medical Device Washers and Washer-Disinfectors
- Use of Published Literature and Previously Submitted Data in PMA Supplements for Class III Medical Devices
- Premarket Notification Requirements for Esophageal and Tracheal Prostheses Including Metal Self-Expandable Stents
- Day-100 Meetings for PMA Applications: Procedures and Implementation
- Class II Device 510k Exemption Process and Evaluation Criteria
- Industry-Supported Scientific and Educational Activities: Maintaining Independence from Promotional Influence
- Direct Final Rulemaking Procedures and Implementation Process
- Maintaining Independence of Industry-Supported Scientific and Educational Activities
- Medical Device Kit Component Certification Requirements for 510k Submissions
- Medical Device Convenience Kits - Premarket Notification and Compliance Requirements
- Design Controls for Medical Device Manufacturers
- Non-Invasive Blood Pressure Monitoring Devices - Testing and Documentation Requirements for 510k Submissions
- Checklist for Orthopedic External Fixation Device Submissions
- Hydroxyapatite Coated Orthopedic Implants - Information for 510k Submissions
- Review Criteria for Phacofragmentation Systems Used in Cataract Surgery
- Review Criteria for Vitreous Aspiration and Cutting Devices
- Export Requirements for Products Not Approved for Sale in the United States
- Barrier Devices for STD Protection During Oral Sex - Requirements for 510k Submissions
- Investigational Device Exemptions (IDE) Requirements for Refractive Surgery Excimer Lasers
- Use of Visible Laser Beam as Emission Indicator for Class II and Class IIIa Laser Products
- Alternative Identification Labeling Requirements for Class I Laser Products Integrated into Other Products
- Use of Reporting Site Registration Number for Medical Device Reports (MDR) Instead of Manufacturing Site Number
- Medical Device Reporting: Manufacturer Report Number Format Variances
- Laser Light Shows and Displays: Requirements for Aircraft Safety and Visual Control
- Format and Content of IDE Progress Reports
- Medical Device Reporting Requirements for User Facilities
- IDE Requirements for Thermal Endometrial Ablation Devices
- Premarket Notification Requirements for Hysteroscopes and Gynecologic Laparoscopes
- Testing Requirements for Healthcare Facility Sterilizers with Non-Traditional Cycle Parameters
- User Instructions for Medical Laser Products: Safety Information and Radiation Hazard Protection Requirements
- Premarket Notification Requirements for Hysteroscopic and Laparoscopic Insufflators
- Preparing 510k Submissions for Medical Exercise Equipment
- Preparing 510k Submissions for Heating and Cooling Therapeutic Devices
- Premarket Notification Requirements for Manual and Powered Wheelchairs and Three-Wheeled Vehicles
- Testing and Labeling Requirements for Non-Latex Male Condoms
- Content and Format Requirements for Medical Laser 510k Submissions
- Testing of Non-Articulating, Mechanically Locked Modular Implant Components in Orthopedic Devices
- Enforcement Policy for X-Ray Assembly Report Filing Requirements
- Recordkeeping Requirements and Exemptions for Portable Home Sunlamp Products and UV Lamps
- Model and Serial Number Labeling Requirements for X-Ray System Components
- Correction and Reporting Requirements for Diagnostic X-Ray Equipment Defects and Noncompliances
- Applicability of Sunlamp Performance Standards to UVA Tanning Products (Revoked)
- Ceramic Ball Hip Systems - Requirements for 510k Premarket Notifications
- 510k Submissions for Mechanical Lithotripters and Stone Dislodgers in Gastroenterology and Urology
- Premarket Notification Requirements for Sterile Lubricating Jelly Used with Transurethral Surgical Instruments
- Premarket Notification Requirements for Conventional and Antimicrobial Foley Catheters with Balloon Retention
- Extended Laparoscopy Devices - Premarket Notification (510k) Submissions
- Cervical Cytology Device Development and Validation Requirements
- Premarket Notification Requirements for Urine Drainage Bags and Accessories
- Testing Requirements for Orthopedic Implants with Modified Metallic Bone-Interface Surfaces
- Regulatory Requirements for Condom-Like Products and Novelty Condoms
- Enforcement Policy for Positive-Beam Limitation Requirements in Diagnostic X-Ray Systems
- Medical Waste Sharps Containers and Secondary Sharps Containers - Design, Testing, and Labeling Requirements
- Premarket Notification Requirements for Aerosol Delivery Devices: Nebulizers, Metered Dose Inhalers, Spacers and Actuators
- Surgical Gowns and Surgical Drapes - Performance Testing and Labeling Requirements
- Endoscope Washers and Washer/Disinfectors - 510k Review Requirements
- Beam Attenuator and Emission Indicator Requirements for Class II and IIIa Visible Laser Systems
- Electromagnetic Compatibility Testing and Safety Requirements for Powered Wheelchairs
- Piston Syringes and Accessories - Review Requirements and Testing Specifications for 510k Submissions
- 510k Requirements for Hypodermic Single Lumen Needles
- Premarket Notification Requirements for Healthcare Facility Sterilizers
- Clinical Electronic Thermometers - Review Requirements and Testing Specifications
- Ureteral Stents - Content and Testing Requirements for 510k Submissions
- Premarket Notification Requirements for Gastroenterology and Urology Biopsy Devices
- Laser Products - Performance Standards and Safety Requirements
- In Vitro Diagnostic Devices for Detection of Parvovirus B19 Antibodies in Human Serum and Plasma
- Shelf Life and Stability Testing for Medical Devices
- Device Labeling Requirements and Content for Premarket Approval Applications
- Quality Assurance Guidelines for Hemodialysis Devices and Facilities
- Labeling Requirements and Recommendations for Medical Devices
- Reinspection of Firms During Pending Legal Actions
- Radiation Control Requirements and Interpretations for Diagnostic X-ray Equipment
- Diagnostic X-Ray Systems: Component Labeling, Assembly, and Safety Requirements
- Radiation Safety Requirements for Diagnostic X-Ray Systems and Components
- Requirements for 510k Submissions for Oxygen Conserving Devices
- Quality Control and Quality Assurance for Sunlamp Products and UV Lamps
- Calibration Constancy Intercomparison System for Microwave Oven Survey Instruments
- Device Master Files - Content, Format, and Submission Requirements
- Color Additives in Medical Devices: Requirements for Direct Body Contact Applications
- Compatibility Criteria for Replacement UV Lamps in Sunlamp Products
- Classification of Large Laser-Based Materials Processing Machines with Walk-In Workstations
- Reproduction of Hazard Warning Labels in User Instructions for Laser Products with Cosmetic Enclosures
- Safety Requirements for Medical Laser Delivery Systems and Interlock Mechanisms
- Exemptions from Reporting Requirements for Limited Production of Sunlamp Products for Commercial Use
- Significant Risk Determination for Investigational Medical Laser Devices
- X-ray Field Size Control Requirements for Fluoroscopic and Spot-Film Systems
- Alternative Warning Statements for Laser Product User Information
- Quality Control Practices for Mercury Vapor Lamp Manufacturing and Testing
- Good Laboratory Practice (GLP) Requirements for Non-Clinical Laboratory Studies
- Clinical and Non-Clinical Testing Requirements for Hysteroscopic Sterilization Devices
- Laser Light Shows and Demonstration Laser Products: Performance Standards and Manufacturer Requirements
- Warning Label Requirements for Multiple Wavelength and Dye Laser Products
- Emergency Use Oxygen Generators and Oxygen Equipment: Flow Rate and Distribution Requirements
- In-House Manufactured Laser Products: Applicability of Federal Performance Standards
- Laser Products Sold in Kit Form: Identification, Certification and Compliance Requirements
- Remote Interlock Connector Requirements for Laser Products
- Viewing Optics Performance Requirements for Surveying Laser Products
- Classification of Electron Beam Accelerators Used as Laser Energy Sources
- Reporting Requirements and Testing Standards for Cabinet X-ray Systems