Radiation-Emitting Products 100
- Appeals Process for Mammography Facilities under MQSA: Adverse Accreditation Decisions, Certificate Actions, and Patient Notifications
- Mammography Quality Standards: Requirements for Facilities, Personnel, Equipment, and Reporting
- Electronic Submission of User Manuals and Radiation Safety Reports for Electronic Products
- Bioresearch Monitoring Program Inspections: Processes and Procedures for Site Evaluations (DRAFT)
- Medical Device User Fee Small Business Qualification and Financial Hardship Waivers (DRAFT)
- Use of Real-World Data and Real-World Evidence to Support Medical Device Regulatory Decision-Making (DRAFT)
- Testing and Labeling of Medical Devices for Magnetic Resonance (MR) Environment Safety and Compatibility
- Premarket Notification Requirements for Magnetic Resonance Diagnostic Devices
- 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
- Technical Performance Assessment and Premarket Requirements for Digital Diagnostic Radiology Display Devices
- Computer-Assisted Detection Devices in Radiology: Performance Testing, Documentation and Labeling Requirements
- Clinical Performance Assessment of Computer-Assisted Detection Devices in Radiology
- Technical Performance Assessment of Quantitative Imaging in Radiological Devices
- Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
- Testing and Performance Requirements for MR Receive-Only Coils for General Diagnostic Use
- Certificates of Confidentiality for Non-Federally Funded Research: Protection of Human Subject Privacy in FDA-Regulated Studies
- Product Recalls, Removals, and Corrections: Procedures and Best Practices
- Performance Standard Requirements for Fluoroscopic X-Ray Systems: Timing, Safety Features and Display Requirements
- Laser Illuminated Projectors (LIPs) - Classification, Safety Requirements and Labeling
- Release of Laboratory Test Results to Responsible Parties Without Freedom of Information Act Requests
- Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices
- Pediatric X-Ray Imaging Device Premarket Submissions: Design, Testing, and Labeling Considerations
- Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies
- Design Considerations and Recommendations for Interoperable Medical Devices
- Solid State X-ray Imaging Devices for Medical Diagnostic Use
- Patient Preference Information in Medical Device Development, Clinical Trials, and Regulatory Decision Making
- Evaluating Appearance Issues and Granting Participation Authorizations for Advisory Committee Members (DRAFT)
- Radiation Biodosimetry Devices: Performance Testing and Documentation Requirements
- Safety of Children's Toy Laser Products
- Considering Whether FDA-Regulated Products Involve Nanotechnology
- Same-Sex Marriage Recognition in Regulatory Definitions of Spouse and Family
- Public Disclosure of Advisory Committee Members' Financial Interests and Waivers
- Radio Frequency Wireless Technology in Medical Devices
- Public Participation in Open Public Hearing Sessions of Advisory Committee Meetings
- Bayesian Statistics in Medical Device Clinical Trials
- Safety Considerations for Hand-Held X-Ray Equipment: Radiation Protection and Testing Requirements
- Voting Procedures for Advisory Committee Meetings
- Preparation and Submission of Advisory Committee Briefing Materials for Public Release
- Inspection and Field Testing Requirements for Sunlamp Products and UV-Emitting Devices
- Inspection and Field Testing Requirements for Radiation-Emitting Electronic Products
- Laser Light Show Variance Renewal and Amendment Procedures
- Safety and Performance Requirements for Cabinet X-ray Security Screening and Industrial Quality Control Systems
- Dear Doctor Letters for Implantable Cardioverter Defibrillator Recalls: Content and Format Recommendations
- Alternative Labeling Methods for Laser Products
- Use of Leftover Human Specimens in IVD Device Studies: Requirements for IDE Exemption and Privacy Protection
- Electronic Distribution of Product Information and Safety Communications
- 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
- Civil Penalties for Electronic Product Radiation Control Violations
- 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
- Electronic Records and Electronic Signatures - Scope and Application
- Assembly, Installation, Adjustment and Testing Information Requirements for Diagnostic X-Ray Systems
- Military Laser Products: Department of Defense Exemption Requirements and Compliance Process
- Laser Light Show Projectors - Variance Requirements and Safety Standards
- Accidental Radioactive Contamination of Human Food and Animal Feeds: Recommendations for State and Local Agencies
- Class II Device 510k Exemption Process and Evaluation Criteria
- Direct Final Rulemaking Procedures and Implementation Process
- IDE Content Requirements for Refractive Surgery Laser Clinical Investigations
- 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
- Laser Light Shows and Displays: Requirements for Aircraft Safety and Visual Control
- Medical Device Reporting Requirements for User Facilities
- User Instructions for Medical Laser Products: Safety Information and Radiation Hazard Protection Requirements
- Content and Format Requirements for Medical Laser 510k Submissions
- 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)
- Enforcement Policy for Positive-Beam Limitation Requirements in Diagnostic X-Ray Systems
- Beam Attenuator and Emission Indicator Requirements for Class II and IIIa Visible Laser Systems
- Laser Products - Performance Standards and Safety Requirements
- 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
- Quality Control and Quality Assurance for Sunlamp Products and UV Lamps
- Calibration Constancy Intercomparison System for Microwave Oven Survey Instruments
- 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
- Good Laboratory Practice (GLP) Requirements for Non-Clinical Laboratory Studies
- Laser Light Shows and Demonstration Laser Products: Performance Standards and Manufacturer Requirements
- Warning Label Requirements for Multiple Wavelength and Dye Laser Products
- 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