Information Collection

Premarket Notification Submission 510(k), Subpart E

IC 5734 under ICR 201504-0910-008 · 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⚠️ Notice: This information collection may be referencing outdated material.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

Document Name Document Type
Form FDA 3514 Premarket Notification Submission 510(k), Subpart E Form and Instruction
FDA 3514 CDRH Premarket Review Coversheet FDA 3514.pdf Form and Instruction
FDA 3541 Premarket Notification [510(K)] Status Request and Respo FDA 3541.pdf Form and Instruction
FDA 3654 Standards Data Report for 510(k)s 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 807 Subpart E 21 CFR 807.90(a)(3) 21 CFR 800.807.93 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	FDA 3514.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3541	Premarket Notification [510(K)] Status Request and Response	FDA 3541.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3654	Standards Data Report for 510(k)s	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: 9,467	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Requested	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	23,584	14,135	9,449
Annual IC Time Burden (Hours)	335,430	603	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.