Information Collection

Premarket Notification Submission 510(k), Subpart E

IC 5734 under ICR 201912-0910-003 · 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⚠️ Notice: This information collection may be referencing outdated material.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 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

IC Title:

Premarket Notification Submission 510(k), Subpart E

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Unchanged

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 807 Subpart E 21 CFR 807.90 21 CFR 800.807.92 21 CFR 800.807.93 21 CFR 807.87

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 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 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	8,999	8,999
Annual IC Time Burden (Hours)	358,633	358,633
Annual IC Cost Burden (Dollars)	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.