View Information Collection (IC)

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 800.807.93 21 CFR 807 Subpart E 21 CFR 807.90(a)(3) 21 CFR 807.87

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	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

Federal Enterprise Architecture Business Reference Module

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 %

	Approved	Program Change Due to New Statute	Program Change Due to Agency Discretion	Change Due to Adjustment in Agency Estimate	Change Due to Potential Violation of the PRA	Previously Approved
Annual Number of Responses for this IC	9,467	0	-3	0	0	9,470
Annual IC Time Burden (Hours)	335,782	0	-269	0	0	336,051
Annual IC Cost Burden (Dollars)	0	0	0	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.