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CDRH Rapid Message Testing with Consumers and Caregivers-May 2023 Renuvion/J-Plasma Device Safety Communication CDRH
 
New
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-FDA Safety Communication Attachment A UPDATE Use of Renuvion J-Plasma Device.pdf Yes No Printable Only
Other-Screener Attachment B Renuvion J-Plasma Device Screener.docx Yes Yes Fillable Fileable
Other-Confirmation of participation email Attachment C Confirmation Email.docx Yes No Printable Only
Other-Interview guide Attachment D Renuvion J-Plasma Device Interview Guide.docx Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

400 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 400 0 400 0 0 0
Annual IC Time Burden (Hours) 36 0 36 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
OMB Memo / Abbreviated Supporting Statement 0678 OMB memo Renuvion J-Plasma Device JC passback.docx 08/15/2023
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.