Lista «A» de tópicos para nuevas guías:
- Postmarket Management of Cybersecurity in Medical Devices
- Medical Device Accessories: Describing Accessories and Classification Pathway for New Accessory Types
- Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices
- Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions
- Suggested Format for Developing and Responding to Deficiencies
- Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics
- Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS) – Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases
- Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS) – Based In Vitro Diagnostics
- Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers
- Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
- 510(k) Third Party Review Program
- New or revised procedural guidances for MDUFA IV implementation