米国｜医療機器分類　関連改正

Device That Detects Nucleic Acid Sequences From Microorganisms Associated With Vaginitis and Bacterial Vaginosis

https://www.federalregister.gov/documents/2025/08/21/2025-16030/medical-devices-immunology-and-microbiology-devices-classification-of-the-device-that-detects

 Anti-Phospholipase A2 Receptor Immunological Test System

https://www.federalregister.gov/documents/2025/08/21/2025-16031/medical-devices-immunology-and-microbiology-devices-classification-of-the-anti-phospholipase-a2

Postnatal Chromosomal Copy Number Variation Detection System

https://www.federalregister.gov/documents/2025/08/21/2025-16032/medical-devices-immunology-and-microbiology-devices-classification-of-the-postnatal-chromosomal-copy

the Liver Iron Concentration Imaging Companion Diagnostic for Deferasirox

https://www.federalregister.gov/documents/2025/08/21/2025-16033/medical-devices-radiology-devices-classification-of-the-liver-iron-concentration-imaging-companion

A Multiplex Respiratory Panel To Detect and Identify Emerging Respiratory Pathogen(s) and Common Respiratory Pathogens in Human Clinical Specimens

https://www.federalregister.gov/documents/2025/08/21/2025-16034/medical-devices-immunology-and-microbiology-devices-classification-of-a-multiplex-respiratory-panel

the Cancer Predisposition Risk Assessment System

https://www.federalregister.gov/documents/2025/08/21/2025-16035/medical-devices-immunology-and-microbiology-devices-classification-of-the-cancer-predisposition-risk

the Menopause Test System

https://www.federalregister.gov/documents/2025/08/21/2025-16036/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the-menopause

 Pharmacogenetic Assessment System

https://www.federalregister.gov/documents/2025/08/21/2025-16037/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the

Mutation Detection Test for Myeloproliferative Neoplasms

https://www.federalregister.gov/documents/2025/08/21/2025-16038/medical-devices-immunology-and-microbiology-devices-classification-of-the-mutation-detection-test

Orthopedic Manual Surgical Instrumentation for Use With Total Disc Replacement Devices

https://www.federalregister.gov/documents/2025/08/21/2025-16039/medical-devices-orthopedic-devices-classification-of-orthopedic-manual-surgical-instrumentation-for

Orthopedic Manual Surgical Instrumentation for Use With Non-Fusion Spinous Process Spacer Devices

https://www.federalregister.gov/documents/2025/08/21/2025-16040/medical-devices-orthopedic-devices-classification-of-orthopedic-manual-surgical-instrumentation-for

Classification of the Laparoscopic Gastrointestinal Sizing Tool

https://www.federalregister.gov/documents/2025/08/21/2025-16041/medical-devices-gastroenterology-urology-devices-classification-of-the-laparoscopic-gastrointestinal