Information Collection

Premarket Notification Submission 5100(k), Subpart E

IC 5734 under ICR 200705-0910-004 · 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⚠️ Notice: This information collection may be referencing outdated material.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 3541 Premarket Notification [510 ( K )] Status Request and Response Premarket Notification Submission 5100(k), Subpart E	Form and Instruction
Form 3654 Standard Data Report for 519 (K)s Premarket Notification Submission 5100(k), Subpart E	Form and Instruction
Form 3514 CDRH Premarket Review Submission Cover Sheet Premarket Notification Submission 5100(k), Subpart E	Form and Instruction
3541 Premarket Notification [510 ( K )] Status Request and Re Form FDA 3541.pdf	Form and Instruction
3654 Standard Data Report for 519 (K)s Form FDA 3654.pdf	Form and Instruction
3514 CDRH Premarket Review Submission Cover Sheet Form FDA 3514.pdf	Form and Instruction

IC Title:

Premarket Notification Submission 5100(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 800.807.87 21 CFR 800.807.81 21 CFR 800.807.92 21 CFR 800.807.93

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	3541	Yes	Yes	Fillable Printable
Form and Instruction	3654	Yes	Yes	Fillable Printable
Form and Instruction	3514	Yes	Yes	Fillable Printable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 3,700

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	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	26,206	106	26,100
Annual IC Time Burden (Hours)	303,528	-55,472	359,000
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.

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