Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
De Novo requests Modified 79 14378 0 Other-De Novo Classification Process (Evaluation of Automatic Class III Designation)
Other-Acceptance Review for De Novo Classification Requests
Other-Electronic Submission Template for Medical Device De Novo Requests
Withdrawal of de novo request Modified 5 1 5 Other-De Novo Classification Process (Evaluation of Automatic Class III Designation)
Other-Acceptance Review for De Novo Classification Requests
Other-Electronic Submission Template for Medical Device De Novo Requests
Other-eSTAR - InVtro Diagnostic Medical Devices
Other-eSTAR - Non-In Vitro Diagnostic Medical Devices
Total burden requested under this ICR: 84 14379 5  
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