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djpope

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djpope

Re: None

Tuesday, 09/12/2017 3:56:11 PM

Tuesday, September 12, 2017 3:56:11 PM

Post# of 18425
Read the whole Document carefully and you will find that it is a Big Deal!

Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions

https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM393978.pdf
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