Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Premarket Notification Submissions Modified 16295 469183 0 Form FDA 3881
Form and Instruction FDA 3514
Form and Instruction FDA 4062
Form and Instruction FDA 4078
Other-Guidance; Recognition and Withdrawal of Voluntary Consensus Standards
Other-Guidance; Refuse to Accept Policy for 510(k)s
Other-eSTAR for summary test reports and data elements
Other-Guidance; Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics New 5 505 0 Other-Guidance; Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics
Total burden requested under this ICR: 16300 469688 0  
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