510(k) 109
- 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
- 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
- Premarket Notification Requirements for Dental Curing Light Devices (DRAFT)
- Premarket Notification Requirements for Dental Composite Resin Devices (DRAFT)
- Animal Testing Recommendations for Dental Bone Grafting Materials (DRAFT)
- Submission Requirements for Terminally Sterilized Medical Devices
- Modifications to Non-Invasive Remote Monitoring Devices for Patient Monitoring During Public Health Emergencies
- Premarket Notification Requirements for Magnetic Resonance Diagnostic Devices
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- When Clinical Data is Needed to Support Substantial Equivalence for 510k Submissions (DRAFT)
- Technical Considerations for Long-Term Implantable Medical Devices Requiring 510k (DRAFT)
- Best Practices for Selecting Predicate Devices in 510k Submissions (DRAFT)
- Labeling Recommendations for Hydrogen Peroxide-Based Contact Lens Care Products
- Testing Considerations for Percutaneous Transluminal Angioplasty (PTA) and Specialty Balloon Catheters
- Testing and Performance Requirements for Soft Daily Wear Contact Lenses
- Animal Testing for Medical Device Safety and Performance Evaluation
- Ultrasonic Diathermy (Physiotherapy) Devices - Technical and Safety Requirements for 510k Submissions
- Marketing Clearance Requirements for Diagnostic Ultrasound Systems and Transducers
- Harmonization of Performance Standards for Diagnostic X-Ray Imaging Systems and Components with IEC Standards
- User Fees and Refunds for 510k Submissions
- MDUFA Performance Goals and Processing of 510k Submissions
- Technical Performance Assessment and Premarket Requirements for Digital Diagnostic Radiology Display Devices
- Clinical Performance Assessment of Computer-Assisted Detection Devices in Radiology
- 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
- Multiple Patient Use Arthroscopy Pump Tubing Sets - Safety, Testing and Labeling Requirements
- Peripheral Vascular Atherectomy Devices - Content and Testing Requirements for 510k Submissions
- 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
- Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Home Use
- Performance Testing and Safety Requirements for Single-Use Cutaneous Recording Electrodes
- Conventional Foley Urinary Catheters - Performance Testing and Labeling Requirements
- Clinical Investigation Requirements for Prostate Tissue Ablation Systems
- 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
- Dual 510k and CLIA Waiver by Application for In Vitro Diagnostic Tests
- Labeling for Intravascular Devices with Lubricious Coatings
- Coronary, Peripheral, and Neurovascular Guidewires - Performance Testing and Documentation Requirements
- 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
- Metal Expandable Biliary Stents and Associated Delivery Systems - Content and Testing Requirements for 510k Submissions
- Non-Clinical Testing Recommendations for Machine Perfusion Devices Used to Preserve Vascularized Human Organs for Transplant
- Testing and Characterization of Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices
- 510k Exemption for Unclassified Medical Devices in Selected Product Categories
- Benefit-Risk Factors to Consider When Evaluating Substantial Equivalence in 510k Submissions
- Heparin in Medical Devices and Combination Products: Testing, Labeling and Safety Requirements
- Technical Considerations for Additive Manufactured Medical Devices
- Pediatric X-Ray Imaging Device Premarket Submissions: Design, Testing, and Labeling Considerations
- 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
- 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
- Postmarket Management of Cybersecurity in Medical Devices
- Benefit-Risk Factors in Medical Device Product Availability, Compliance, and Enforcement Decisions
- Clinical Trial Considerations for Neurological Devices Intended to Slow, Stop, or Reverse Disease Progression
- Labeling Requirements for Permanent Hysteroscopic Tubal Implants for Female Sterilization
- Reporting of Computational Modeling and Simulation Studies in Medical Device Submissions
- Solid State X-ray Imaging Devices for Medical Diagnostic Use
- Bipolar Electrosurgical Vessel Sealers for General Surgery - Performance Testing and Labeling Requirements
- In Vitro Companion Diagnostic Device and Therapeutic Product Co-Development (DRAFT)
- Technical Performance Assessment of Digital Whole Slide Imaging Systems in Anatomic Pathology
- 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
- Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization Test Systems for Bone Marrow Specimens
- 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
- Infusion Pumps - Total Product Life Cycle Recommendations for Safety and Performance
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
- Contact Lens Care Product Labeling: Warnings, Instructions and Readability Requirements
- Intravascular Administration Sets and Accessories - Testing and Documentation Requirements
- Hemodialysis Blood Tubing Sets - Performance, Testing, and Labeling Requirements
- Coronary and Carotid Embolic Protection Devices - Performance Testing and Labeling Requirements
- Medical Gloves - Premarket Notification, Quality System, Labeling and Compliance Requirements
- Biological Indicators for Healthcare Facility Sterilization Process Monitoring - 510k Submission Requirements
- Keratomes and Replacement Keratome Blades for Corneal Surgery
- Tonometers for Measuring Intraocular Pressure - Testing and Performance Requirements
- Dental Curing Lights - Performance Testing and Safety Requirements
- Menstrual Tampons and Menstrual Pads - Testing and Labeling Requirements for 510k Submissions
- Validation Data Requirements for Reprocessed Single-Use Medical Devices
- Premarket Requirements for Nitric Oxide Delivery Systems and Gas Analyzers
- Premarket Notification Requirements for Penile Rigidity Implants
- Liquid Chemical Sterilants and High Level Disinfectants - Content and Format of 510k Submissions
- Male Latex Condoms - Abbreviated 510k Submissions Using Consensus Standards
- Premarket Notification Requirements for Hysteroscopes and Gynecologic Laparoscopes
- Premarket Notification Requirements for Urine Drainage Bags and Accessories
- Medical Waste Sharps Containers and Secondary Sharps Containers - Design, Testing, and Labeling Requirements
- Surgical Gowns and Surgical Drapes - Performance Testing and Labeling Requirements
- Endoscope Washers and Washer/Disinfectors - 510k Review Requirements
- 510k Requirements for Hypodermic Single Lumen Needles
- Premarket Notification Requirements for Healthcare Facility Sterilizers
- Requirements for 510k Submissions for Oxygen Conserving Devices