First Year (one time)

Guidance Medical Device ISO 13485: 2003 Voluntary Audit Report Submission Pilot Program

Documents and Forms

Document Name Document Type
ISO13485 eSubmitter Screenshots.doc Other-Screenshots

Information Collection (IC) Details

IC Title:	First Year (one time)	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Screenshots			ISO13485 eSubmitter Screenshots.doc		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 567	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	567	34	533
Annual IC Time Burden (Hours)	23,814	1,428	22,386
Annual IC Cost Burden (Dollars)	17,010	1,020	15,990

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.