Information Collection

Premarket Notification Submission 510(k), Subpart E

IC 5734 under ICR 201703-0910-017 · 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⚠️ Notice: This information collection may be referencing outdated material.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 CDRH Premarket Review Coversheet Premarket Notification Submission 510(k), Subpart E	Form and Instruction
Form FDA 3541 Premarket Notification [510(K)] Status Request and Response Premarket Notification Submission 510(k), Subpart E	Form and Instruction
Form FDA 3654 Standards Data Report for 510(k)s 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: 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:

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

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.

Something went wrong when downloading this file. If you have any questions, please send an email to [email protected].