Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Certificate of Compliance w/42 CFR part 11 New 40 30 0 Form and Instruction FDA 3674 Certificate of Compliance (42 CFR 11)
Premarket Approval of Medical Devices: Maintenance of Records Modified 552 9384 0
Premarket Approval of Medical Devices: Reporting Modified 3444 343466 0 Other-Agency Guidance
Form and Instruction FDA 3674 Certificate of Compliance
Other-Agency Guidance
Total burden requested under this ICR: 4036 352880 0  
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