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⚠️ Notice: This information collection may be referencing outdated material.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 3514 Premarket Notification Submission 510(k), Subpart E Form and Instruction
FDA 3514 CDRH Premarket Review Coversheet 0120_Form_FDA-3514.pdf Form and Instruction
FDA 3541 Premarket Notification [510(K)] Status Request and Respo 0120_Form_FDA-3541.pdf Form and Instruction
FDA 3654 Standards Data Report for 510(k)s 0120_Form_FDA-3654.pdf Form and Instruction

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Premarket Notification Submission 510(k), Subpart E	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 800.807.92 21 CFR 800.807.93 21 CFR 807 Subpart E 21 CFR 807.90 21 CFR 807.87

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	FDA 3514	CDRH Premarket Review Coversheet	0120_Form_FDA-3514.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3541	Premarket Notification [510(K)] Status Request and Response	0120_Form_FDA-3541.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3654	Standards Data Report for 510(k)s	0120_Form_FDA-3654.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: 8,999	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	8,999	-450	9,449
Annual IC Time Burden (Hours)	358,633	23,806	334,827
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.