Food And Drug Administration

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Medical Devices; Anesthesiology Devices; Classification of the Over-the-Counter Device To Assess Risk of Sleep Apnea

ID: 2026-22182
• Jurisdiction: United States
• Authority: Food and Drug Administration
• Date: 2026-10-30
• Language: English
• Pages: 4

Medical Devices; General and Plastic Surgery Devices; Classification of the Software-Aided Adjunctive Diagnostic Device for Use by Physicians on Lesions Suspicious for Skin Cancer

ID: 2026-22179
• Jurisdiction: United States
• Authority: Food and Drug Administration
• Date: 2026-10-30
• Language: English
• Pages: 3

Medical Devices; Radiology Devices; Classification of the Radiology Software for Referral of Findings Related to Fibrotic Lung Disease

ID: 2026-22180
• Jurisdiction: United States
• Authority: Food and Drug Administration
• Date: 2026-10-30
• Language: English
• Pages: 4

Medical Devices; Anesthesiology Devices; Classification of the Spinal Imaging System for Neuraxial Procedures

ID: 2026-22181
• Jurisdiction: United States
• Authority: Food and Drug Administration
• Date: 2026-10-30
• Language: English
• Pages: 3

Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability

ID: 2026-21669
• Jurisdiction: United States
• Authority: Food and Drug Administration
• Date: 2026-10-23
• Language: English
• Pages: 2

Action Levels for Cadmium in Processed Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability

ID: 2026-21670
• Jurisdiction: United States
• Authority: Food and Drug Administration
• Date: 2026-10-23
• Language: English
• Pages: 2

Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate

ID: 2026-20979
• Jurisdiction: United States
• Authority: Food And Drug Administration
• Date: 2026-10-14
• Language: English
• Pages: 2

Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods

ID: 2026-20848
• Jurisdiction: United States
• Authority: Food and Drug Administration
• Date: 2026-10-13
• Language: English
• Pages: 31

Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorganism(s) Causing Sexually Transmitted Infections Using Home-Collected Specimens

ID: 2026-20727
• Jurisdiction: United States
• Authority: Food and Drug Administration
• Date: 2026-10-09
• Language: English
• Pages: 5

Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants; Draft Guidance for Industry; Availability

ID: 2026-20721
• Jurisdiction: United States
• Authority: Food And Drug Administration
• Date: 2026-10-09
• Language: English
• Pages: 3

Medical Devices; Immunology and Microbiology Devices; Classification of the Hematopoietic Cell Enrichment Kit

ID: 2026-20725
• Jurisdiction: United States
• Authority: Food And Drug Administration
• Date: 2026-10-09
• Language: English
• Pages: 3

Medical Devices; Cardiovascular Devices; Classification of the Infant Pulse Rate and Oxygen Saturation Monitor for Over-the-Counter Use

ID: 2026-20726
• Jurisdiction: United States
• Authority: Food And Drug Administration
• Date: 2026-10-09
• Language: English
• Pages: 3

Medical Devices; Immunology and Microbiology Devices; Classification of the High Throughput DNA Sequencing for Hereditary Cancer Predisposition Assessment Test System

ID: 2026-20443
• Jurisdiction: United States
• Authority: Food and Drug Administration
• Date: 2026-10-06
• Language: English
• Pages: 5

Medical Devices; Exemptions From Premarket Notification: Class II Devices; Certain Clinical Toxicology Test Systems

ID: 2026-20448
• Jurisdiction: United States
• Authority: Food and Drug Administration
• Date: 2026-10-06
• Language: English
• Pages: 10

Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound System for Non-Thermal, Mechanical Tissue Ablation

ID: 2026-20440
• Jurisdiction: United States
• Authority: Food And Drug Administration
• Date: 2026-10-06
• Language: English
• Pages: 3

Medical Devices; Cardiovascular Devices; Classification of the Hyperoxia Monitoring Device Adjunct to Pulse Oximetry

ID: 2026-20441
• Jurisdiction: United States
• Authority: Food And Drug Administration
• Date: 2026-10-06
• Language: English
• Pages: 3

Medical Devices; Gastroenterology-Urology Devices; Classification of the Flushing and Storage Solution for Vascular Autografts at Room Temperature

ID: 2026-20075
• Jurisdiction: United States
• Authority: Food And Drug Administration
• Date: 2026-09-30
• Language: English
• Pages: 3

Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2 Inactive Bakers Yeast

ID: 2026-19656
• Jurisdiction: United States
• Authority: Food and Drug Administration
• Date: 2026-09-25
• Language: English
• Pages: 5

Nonclinical Testing Terminology

ID: 2026-19350
• Jurisdiction: United States
• Authority: Food and Drug Administration
• Date: 2026-09-22
• Language: English
• Pages: 17

Nonclinical Testing Terminology

ID: 2026-19349
• Jurisdiction: United States
• Authority: Food and Drug Administration
• Date: 2026-09-22
• Language: English
• Pages: 16

Medical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triage and Notification Devices

ID: 2026-19074
• Jurisdiction: United States
• Authority: Food And Drug Administration
• Date: 2026-09-17
• Language: English
• Pages: 3

Medical Devices; Cardiovascular Devices; Classification of the Cardiovascular Machine Learning-Based Notification Software

ID: 2026-18612
• Jurisdiction: United States
• Authority: Food And Drug Administration
• Date: 2026-09-11
• Language: English
• Pages: 3

Medical Devices; General Hospital and Personal Use Devices; Classification of the Whole Room Microbial Reduction Device

ID: 2026-18426
• Jurisdiction: United States
• Authority: Food and Drug Administration
• Date: 2026-09-10
• Language: English
• Pages: 3

Medical Devices; Radiology Devices; Classification of the Vaginal Hydrogel Packing System

ID: 2026-18427
• Jurisdiction: United States
• Authority: Food and Drug Administration
• Date: 2026-09-10
• Language: English
• Pages: 3

Medical Devices; Gastroenterology-Urology Devices; Classification of the Implanted Tibial Electrical Urinary Continence Device

ID: 2026-18428
• Jurisdiction: United States
• Authority: Food and Drug Administration
• Date: 2026-09-10
• Language: English
• Pages: 4
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