Information Collection List

IC Title	Status	Responses	Hours	Dollars	Document Type	Form No.	Form Name
Premarket Notification Submissions	Unchanged	12670	323379	0	Form	FDA 3881	Indications for Use
					Form and Instruction	FDA 3514	CDRH Premarket Review Submission Cover Sheet
					Form and Instruction	FDA 4062	electronic Submission Template and Resource (eSTAR)
					Form and Instruction	FDA 4078	IVD electronic Submission Template and Resource (eSTAR)
					Other-guidance
					Other-guidance
					Other-eSTAR for summary test reports and data elements
					Other-Agency Guidance
Total burden requested under this ICR:		12670	323379	0
To view an IC, click on IC Title