Device Trade Group Identifies Highest-Priority FDA Guidance

AdvaMed has issued a list of nine planned FDA guidance documents that are most relevant to device makers for 2017.

The industry group flagged the following documents:

• Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices;
• New or revised procedural guidances for MDUFA IV implementation;
• Suggested Format for Developing and Responding to Deficiencies of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS) – Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases;
• 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;
• Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices;
• Related replacement reagent and instrument policy; and
• UDIs.