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Q-Submission and Early Payor Feedback Request Programs for Medical Devices
ICR 202212-0910-007
OMB: 0910-0756
Federal Form Document
OMB.report
HHS/FDA
OMB 0910-0756
ICR 202212-0910-007
( )
Forms and Documents
Document
Name
Status
0756 CDRH Q-Sub and Early Payor Feedback Programs REV SSA 2023.docx
Supporting Statement A
2022-12-28
IC Document Collections
IC ID
Document
Title
Status
257633
Early Payor Feedback Program (EPFP)
Other-Agency Template
New
209237
(CDRH/CBER) Q-Submissions using eSTAR - includes eSTAR Setup
Other-Agency Template
Modified
209236
(CDRH/CBER) Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
Other-Presubmissions Guidance
Modified
ICR Details
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