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CDRH Rapid Message Testing with Consumers and Caregivers- November 2022 Pulse Oximeter Safety Communication CDRH
 
New
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Attachment A - FDA Safety Communication Attachment A_Pulse Oximeter Accuracy and Limitations_ FDA Safety Communication _ FDA.pdf Yes No Printable Only
Other-Attachment A1 - Advisory Committee meeting web page Attachment A1--11-01-22 Advisory Committee mtg page.pdf Yes No Printable Only
Other-Attachment B - Screener Attachment B_MSG6 Pulse Oximeters_Screener 9-27-23.docx Yes Yes Fillable Fileable
Other-Attachment C - Confirmation Email Attachment C_Confirmation Email--CDRH 09-27-23.docx Yes Yes Fillable Fileable
Other-Attachment D - Interview Guide Attachment D_MSG6 Pulse Oximeters_Interview Guide_9-27-23.docx Yes Yes Printable Only

Health Consumer Health and Safety

 

525 0
   
Individuals or Households
 
   100 %

  Approved Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 588 0 588 0 0 0
Annual IC Time Burden (Hours) 48 0 48 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
OMB Memo 0678-memo-#6 Pulse oximeters 9-27-23.docx 09/27/2023
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