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Federal forms, ICRs, and supporting documents

Information Collection

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

IC 209236 under ICR 202505-0910-013 · OMB 0910-0756.

Documents and Forms
Document Name
Document Type
Other-Guidance; Requests for Feedbac
Other-Agency Template
Information Collection (IC) Details

View Information Collection (IC)

(CDRH/CBER) Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
 
No Modified
 
Voluntary
 

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 Guidance; Requests for Feedback and Meetings for Medical Device Submission_ The Q-Submission Program.pdf 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 PRAQuestionFieldsforQSub.docx Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

5,810 200
   
Private Sector Businesses or other for-profits
 
   100 %

  Requested 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 5,810 0 0 3,590 0 2,220
Annual IC Time Burden (Hours) 795,970 0 0 491,830 0 304,140
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
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