IVDs (In Vitro Diagnostic Devices) 28
- Validation of In Vitro Diagnostic Tests for Emerging Pathogens During Public Health Emergencies (DRAFT)
- Laboratory Developed Tests (LDTs) Enforcement Discretion Policy and Phased Compliance Requirements
- Bioresearch Monitoring Program Inspections: Processes and Procedures for Site Evaluations (DRAFT)
- Policy for Laboratory Tests Used in Response to Chemical, Biological, Radiological, or Nuclear Public Health Emergencies (DRAFT)
- Enforcement Policies for Unauthorized Diagnostic Tests During Public Health Emergencies (DRAFT)
- 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
- Testing for Biotin Interference in In Vitro Diagnostic Devices Using Biotin/Avidin Technology
- Blood Glucose Monitoring Systems for Prescription Point-of-Care Use - Performance Standards and Technical Requirements
- Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices
- Distribution of LOINC Codes for In Vitro Diagnostic Tests by Manufacturers
- Use of Genetic Variant Databases as Sources of Valid Scientific Evidence for Clinical Validity of Genetic Tests
- Investigational In Vitro Diagnostic Devices Used in Therapeutic Product Clinical Trials (DRAFT)
- 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
- 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
- Procedures for Medical Devices Advisory Committee Panel Meetings
- In Vitro Companion Diagnostic Device and Therapeutic Product Co-Development (DRAFT)
- Technical Performance Assessment of Digital Whole Slide Imaging Systems in Anatomic Pathology
- Radiation Biodosimetry Devices: Performance Testing and Documentation Requirements
- 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
- Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices
- Research Use Only and Investigational Use Only In Vitro Diagnostic Products - Labeling and Distribution Requirements
- Migration Studies for In Vitro Diagnostic Devices Moving to New Systems
- In Vitro Diagnostic Device Studies Exempt from Investigational Device Exemption Requirements
- In Vitro Diagnostic Devices for Detection of Parvovirus B19 Antibodies in Human Serum and Plasma