Electronic Submission of Voluntary Allegations to CDRH

Submission to CDRH Allegations of Regulatory Misconduct Associated with Medical Devices

Documents and Forms

Document Name Document Type
Reporting Allegations of Regulatory Misconduct - Intro Screen.pdf Instruction
Reporting Allegations of Regulatory Misconduct - Intro Screen.pdf Instruction
Reporting Allegations of Regulatory Misconduct - Form.pdf Other-Form
Reporting Allegations of Regulatory Misconduct _ FDA 11-01-23 (002).pdf Other-Form

Information Collection (IC) Details

IC Title:	Electronic Submission of Voluntary Allegations to CDRH	Agency IC Tracking Number:	CDRH

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
Instruction			Reporting Allegations of Regulatory Misconduct - Intro Screen.pdf		Yes	No	Printable Only
Other-Form			Reporting Allegations of Regulatory Misconduct _ FDA 11-01-23 (002).pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 2,500	Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 95 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	2,500	900	1,600
Annual IC Time Burden (Hours)	625	225	400
Annual IC Cost Burden (Dollars)	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.