USFDA

CDRH New - October 20, 2021

U.S. Food and Drug Administration sent this bulletin at 10/20/2021 09:01 AM EDT

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U.S. Food and Drug Administration - CDRH New

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October 20, 2021

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on October 19, 2021. To view listings for other dates, see CDRH New - News and Updates.

  • Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products - Draft Guidance for Industry and Food and Drug Administration Staff
  • Hearing Aids (Updated)
  • Other Hearing Devices and Products (Updated)
  • Webinar on Proposed Rule for Establishing Over-the-Counter Hearing Aids and Draft Guidance for Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products
  • Federal Register: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Availability
  • Federal Register: Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids

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