OMB
.report
Search
Premarket Notification Submissions
Premarket Notification Submission 510(k), Subpart E
OMB: 0910-0120
IC ID: 5734
OMB.report
HHS/FDA
OMB 0910-0120
ICR 202306-0910-007
IC 5734
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0120 can be found here:
2023-08-28 - No material or nonsubstantive change to a currently approved collection
Documents and Forms
Document Name
Document Type
Form FDA 3881
Premarket Notification Submissions
Form
FDA 3881 Indications for Use
FDA-3881.pdf
Form
FDA 3514 CDRH Premarket Review Submission Cover Sheet
FDA-3514.pdf
Form and Instruction
FDA 4062 electronic Submission Template and Resource (eSTAR)
eSTAR (static) FDA 4062.pdf
Form and Instruction
FDA 4078 IVD electronic Submission Template and Resource (eSTAR)
IVD eSTAR (static) FDA 4078.pdf
Form and Instruction
Recognition of Standards and Withdrawal.docx
Other-guidance
RTA guidance.pdf
Other-guidance
0120_ASCA STR format.docx
Other-eSTAR for summary test reports and data elements
COVID-Transition-Enforcement-Guidance MARCH 2023.pdf
Other-Agency Guidance
Information Collection (IC) Details
© 2024 OMB.report |
Privacy Policy