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August 27, 2024

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on August 26, 2024. To view listings for other dates, see CDRH New - News and Updates.

• eMDR System Enhancements (Updated)
• Coding Resources for Medical Device Reports (Updated)
• Health Level Seven (HL7) Individual Case Safety Reporting (ICSR) Files (Updated)
• MDR Data Files (Updated)
• Voluntary Recall of SoClean Equipment Intended for Use with CPAP Devices and Accessories: FDA Safety Communication (Updated)
• Federal Register: Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide; Guidance for Industry and Food and Drug Administration Staff; Availability
• Federal Register: Withdrawal of Approval and Amending of Mammography Quality Standards Act Alternative Standards