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

Q-Submission and Early Payor Feedback Request Programs and Medical Device Development Tools

Documents and Forms

Document Name Document Type

no available documents/forms check other ICs listed under this ICR

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-Guidance; Requests for Feedback and Meetings for Medical Device Submission - The Q-Submission Program				https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program	Yes	Yes	Fillable Fileable
Other-Agency Template					Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 5,810	Number of Respondents for Small Entity: 200

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

Percentage of Respondents Reporting Electronically: 100 %

	Requested	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	5,810	3,590	2,220
Annual IC Time Burden (Hours)	795,970	491,830	304,140
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.

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