Medical Device Labeling Regulations; Third-Party Disclosure

Medical Device Labeling Regulations

OMB: 0910-0485

IC ID: 232983

Information Collection (IC) Details

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Medical Device Labeling Regulations; Third-Party Disclosure CDRH
 
No Unchanged
 
Mandatory
 
21 CFR 660, 800; 801; 809; 1040  (To search for a specific CFR, visit the Code of Federal Regulations.)

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Agency Guidance 0577 Prominent-and-Conspicuous-Mark-of-Manufacturers-on-Single-Use-Devices GFI.pdf https://www.fda.gov/media/71187/download Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

102,758 0
   
Private Sector Businesses or other for-profits
 
   95 %

  Requested 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 20,447,205 0 0 0 0 20,447,205
Annual IC Time Burden (Hours) 8,485,061 0 0 0 0 8,485,061
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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