Information Collection

Premarket Notification Submission 5100(k), Subpart E

IC 5734 under ICR 201008-0910-006 · 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⚠️ Notice: This information collection may be referencing outdated material.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 5100(k), Subpart E	Form and Instruction
FDA 3514 CDRH Premarket Review Submission Cover Sheet Form 3514.pdf	Form and Instruction
FDA 3541 Premarket Notification 510(K) Form 3541.pdf	Form and Instruction
FDA 3654 Standards Data Report for 510(k)s Form 3654.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 800.807.92 21 CFR 800.807.93 21 CFR 807 Subpart E 21 CFR 807.90(a)(3) 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 Submission Cover Sheet	Form 3514.pdf	Yes	Yes	Fillable Printable
Form and Instruction	FDA 3541	Premarket Notification 510(K)	Form 3541.pdf	Yes	Yes	Fillable Printable
Form and Instruction	FDA 3654	Standards Data Report for 510(k)s	Form 3654.pdf	Yes	Yes	Fillable Printable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 3,800

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	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	9,474	-16,732	26,206
Annual IC Time Burden (Hours)	336,233	32,705	303,528
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.