(CDRH/CBER) Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program

Q-Submission and Early Payor Feedback Request Programs for Medical Devices

Documents and Forms

Document Name Document Type
Q-Submission-Feedback-Meetings-Guidance.pdf Other-Presubmissions Guidance
Q-Submission-Feedback-Meetings-Guidance.pdf Other-Presubmissions Guidance
PRAQuestionFieldsforQSub.docx Other-Agency Template
PRAQuestionFieldsforQSub.docx Other-Agency Template

Information Collection (IC) Details

IC Title:	(CDRH/CBER) Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program	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-Presubmissions Guidance			Q-Submission-Feedback-Meetings-Guidance.pdf		Yes	Yes	Fillable Fileable
Other-Agency Template			PRAQuestionFieldsforQSub.docx		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 2,220	Number of Respondents for Small Entity: 200

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

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	2,220	-1,282	3,502
Annual IC Time Burden (Hours)	304,140	-175,634	479,774
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.