Information Collection

Premarket Notification Submissions

IC 5734 under ICR 202306-0910-007 · OMB 0910-0120.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
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

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:

table that charts list of 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 %

table that charts list of burden
	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

table that charts IC Documents
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.