CDRH Rapid Message Testing with Consumers and Caregivers -- March 2023 Breast Implant Safety Communication

Testing Communications On Medical Devices and Radiation-Emitting Products

OMB: 0910-0678

IC ID: 261063

Documents and Forms
Document Name
Document Type
Other-Attachment A - FDA Safety Comm
Other-Attachment B - Screener
Other-Appendix C - Confirmation Emai
Other-Attachment D - Interview Guide
IC Document
Information Collection (IC) Details

View Information Collection (IC)

CDRH Rapid Message Testing with Consumers and Caregivers -- March 2023 Breast Implant 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, "Update: Reports of Squamous Cell Carcinoma in the Capsule Around Breast Implants" Attachment A_UPDATE_ Reports of Squamous Cell Carcin--07-13-23.pdf Yes No Printable Only
Other-Attachment B - Screener Attachment B_MSG4 Breast Implant_Screener--07-13-23.docx Yes Yes Fillable Fileable
Other-Appendix C - Confirmation Email Attachment C_Confirmation Email--07-13-23.docx Yes No Printable Only
Other-Attachment D - Interview Guide Attachment D_MSG4 Breast Implant_Interview Guide--07-13-23.docx Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

450 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 504 0 504 0 0 0
Annual IC Time Burden (Hours) 41 0 41 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
OMB Memorandum 0678-memo-#4 Breast Implant Safety Communication--07-13-23.docx 07/13/2023
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