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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