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The FDA changed its workspace from Google Workspace to Microsoft Outlook. At present, there is no equivalent email for this in the Microsoft Office 365 and the FDA is still in the process of creating the common email.

In view of this change, an Application Holiday is hereby declared from November 24-25 and December 1-2, 2022.  During this period, Center for Device Regulation, Radiation Health, and Research (CDRRHR) will not receive the following types of medical device applications:

  1. Initial Certificate of Product Registration of Medical Device including In Vitro Diagnostic Medical Device
  2. Initial Certificate of Health Related Device Registration (CHRDR) of Water Purification Equipment and Device
  3. Initial CHRDR of Equipment or Devices Used for Treating Sharps, Pathological and Infectious Wastes

For your information and guidance.