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April 30, 2024

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on April 29, 2024. To view listings for other dates, see CDRH New - News and Updates.

• Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564 - Draft Guidance for Laboratory Manufacturers and Food and Drug Administration Staff
• Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency - Draft Guidance for Industry and Food and Drug Administration Staff
• Webinar - Final Rule: Medical Devices; Laboratory Developed Tests - May 14, 2024
• Laboratory Developed Tests: Frequently Asked Questions
• Laboratory Developed Tests (Updated)
• Class I Recall: SonarMed Inc. Recalls Airway Acoustic Sensors Due to a Restricted Inner Diameter of Airway Causing Suction Catheter Passage Difficulty
• Class I Recall: SonarMed Inc. Recalls Airway Monitors Due to a Software Anomaly Resulting in Failure to Detect a Partial Obstruction in 2.5mm Sensors and Up To 3mm Distal to the Sensor Tip
• Federal Register: Laboratory Developed Tests
• Federal Register: Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564
• Federal Register: Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency