Certification of Compliance with 42 U.S.C. § 282(j)(5)(B)

Medical Devices; Humanitarian Use Devices

OMB: 0910-0332

IC ID: 258995

Information Collection (IC) Details

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Certification of Compliance with 42 U.S.C. § 282(j)(5)(B)
 
No New
 
Mandatory
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form FDA 3674 Certification of Compliance with 42 USC 282(j)(5)(B) Form FDA 3674 Cert of Compliance 42 CFR part 11.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

4 0
   
Private Sector Businesses or other for-profits
 
   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 4 0 0 4 0 0
Annual IC Time Burden (Hours) 3 0 0 3 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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