Premarket Notification Submissions

Premarket Notification Submission 510(k), Subpart E

OMB: 0910-0120

IC ID: 5734

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