Premarket Notification Submissions

Premarket Notification Submission 510(k), Subpart E

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0120 can be found here:

Documents and Forms

Document Name Document Type
Form FDA 3881 Premarket Notification Submissions Form
Recognition of Standards and Withdrawal.docx Other-guidance
Recognition of Standards and Withdrawal.docx Other-guidance
RTA guidance.pdf Other-guidance
RTA guidance.pdf Other-guidance
0120_ASCA STR format.docx Other-eSTAR for summary test reports
0120_ASCA STR format.docx Other-eSTAR for summary test reports
COVID-Transition-Enforcement-Guidance MARCH 2023.pdf Other-Agency Guidance
COVID-Transition-Enforcement-Guidance MARCH 2023.pdf Other-Agency Guidance
FDA 3881 Indications for Use FDA-3881.pdf 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 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 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
FDA 4078 IVD electronic Submission Template and Resource (eSTAR) IVD eSTAR (static) FDA 4078.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	Premarket Notification Submissions	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 807, subpart E (807.81-807.100 (To search for a specific CFR, visit the Code of Federal Regulations.)

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form	FDA 3881	Indications for Use	FDA-3881.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3514	CDRH Premarket Review Submission Cover Sheet	FDA-3514.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 4062	electronic Submission Template and Resource (eSTAR)	eSTAR (static) FDA 4062.pdf	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 4078	IVD electronic Submission Template and Resource (eSTAR)	IVD eSTAR (static) FDA 4078.pdf	Yes	Yes	Fillable Fileable Signable
Other-guidance			Recognition of Standards and Withdrawal.docx	Yes	No	Printable Only
Other-guidance			RTA guidance.pdf	Yes	Yes	Printable Only
Other-eSTAR for summary test reports and data elements			0120_ASCA STR format.docx	Yes	Yes	Fillable Fileable Signable
Other-Agency Guidance			COVID-Transition-Enforcement-Guidance MARCH 2023.pdf	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 3,800	Number of Respondents for Small Entity: 1,050

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	12,670	3,671	8,999
Annual IC Time Burden (Hours)	323,379	4,210	319,169
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

Title	Document	Date Uploaded
No associated records found

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.