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 In this section:

                About ESG

About ESG

                        User Guide
          ESG Account Management Portal User Guide
          Submission Statistics
          Impact of the Gateway
          Center Submission Types
          Submission Acknowledgements
          ESG Submission Process
          Planned Maintenance and Status History
          Submission Times Home
          For Industry
          Electronic Submissions Gateway
          About ESG
          Center Submission TypesAbout ESG Center Submission Types
  
  	
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Legend:(A)
			denotes AS2 only.(W)
			denotes WebTrader only.(P)
			denotes Production environment only.(T)
			denotes Test environment only.(NGP)
			denotes Not for General Public.(*)
			CDRH's only eligible submission categories via the FDA ESG CDRH "Electronic_Submissions" submission type are "Recall Reports of Corrections and Removals" and "Radiological Health Reports and Correspondence". Further, CDRH Premarket submissions should be sent via the CDRH Customer Collaboration Portal.***Note:*** If a WebTrader Display Name or an AS2 Submission Type does not have either the (P) or (T) annotation, then it is allowed in both Production and Test.***Note:*** If an item does not have the (W) or (A) annotation, then it is allowed in both WebTrader and AS2.Center
			WebTrader Display Name
			AS2 Submission Type
			AS2 Routing IDCBER
			510K
			510K
			CBER_510KAERS
			AERS
			FDA_AERSAERS Attachments
			AERS_ATTACHMENTS
			FDA_AERS_ATTACHMENTSAERS_PREMKT_CBER
			AERS_PREMKT_CBER
			FDA_AERS_PREMKT_CBERAERS_ATTACHMENTS_PREMKT_CBER
			AERS_ATTACHMENTS_PREMKT_CBER
			FDA_AERS_ATTACHMENTS_PREMKT_CBERBEST
			BEST
			CBER_BESTCDISC
			CDISC
			CBER_CDISCEBLA
			EBLA
			CBER_EBLAeDMF
			eDMF
			CBER_EDMFEIDE
			EIDE
			CBER_EIDEEIND
			EIND
			CBER_EINDEUA
			EUA
			CBER_EUAH1N1_Lot_Release (A)
			CBER_H1N1_LOT_RELEASELot_Release_Protocol
			Lot_Release_Protocol
			CBER_LOT_RELEASE_PROTOCOLNDA
			NDA
			CBER_NDAPMA
			PMA
			CBER_PMAPre_IND
			PRE_IND
			CBER_PRE_INDPromotional_Materials
			Promotional_Materials
			CBER_PROMOTIONAL_MATERIALQSUBS
			QSUBS
			CBER_QSUBSSEND_PILOT (T)
			SEND_PILOT (T)
			CBER_SEND_PILOTSPL_LDD
			SPL_LDD
			CBER_SPLLDVAERS
			VAERS
			CBER_VAERSCDER
			ACA6004_Drug_Samples
			ACA6004_Drug_Samples
			CDER_ACA6004AERS
			AERS
			FDA_AERSAERS Attachments
			AERS_ATTACHMENTS
			FDA_AERS_ATTACHMENTSAERS IND (T)
			AERS_IND (T)
			AERS_INDAERS Attachment IND (T)
			AERS_ATTACHMENTS_IND (T)
			AERS_ATTACHMENTS_INDAERS_PREMKT (T)
			AERS_PREMKT (T)
			FDA_AERS_PREMKTAERS_Attachments_PREMKT (T)
			AERS_Attachments_PREMKT (T)
			FDA_AERS_ATTACHMENTS_PREMKTAERS_PREMKT_CDER
			AERS_PREMKT_CDER
			FDA_AERS_PREMKT_CDERAERS_ATTACHMENTS_PREMKT_CDER
			AERS_ATTACHMENTS_PREMKT_CDER
			FDA_AERS_ATTACHMENTS_PREMKT_CDERECTD
			ECTD
			CDER_ECTDECTD WAIVED
			ECTD_WAIVED
			CDER_ECTD_WAIVEDEDMF TYPEIII
			EDMF_TYPEIII
			CDER_EDMF_TYPEIIIEIND
			EIND
			CDER_EINDFFU-PILOT (T)
			FFU-PILOT (T)
			CDER_FFU-PILOTGDUFA_Facility_Registration
			GDUFA_Facility_Registration
			CDER_GDUFA_FACILITY_REGISTRATIONPFC
			PFC
			CDER_PFCVoluntary_Direct_AEs (W)CDRH
			Adverse Events
			Adverse_Events
			CDRH_AERSElectronic_Submissions (*)
			Electronic_Submissions (*)
			CDRH_ESUBSGUDID
			GUDID
			CDRH_GUDIDCFSAN
			
			DSR_Adverse_Events (A)
			CFSAN_DSR_ADVERSE_EVENTSEON-Payload-Files (P)
			EON-Payload-Files (P)
			CFSAN_EON_PAYLOAD_FILESFood_Pilot_Listing (P)
			Food_Pilot_Listing (P)
			CFSAN_FOOD_PILOT_LISTINGForm3479
			Form3479
			CFSAN_Form3479Form3480
			Form3480
			CFSAN_FORM3480Form3480A
			Form3480A
			CFSAN_FORM3480AForm3503
			Form3503
			CFSAN_FORM3503Form3665
			Form3665
			CFSAN_FORM3665Form3666
			Form3666
			CFSAN_FORM3666Form3667
			Form3667
			CFSAN_FORM3667NDI (P)
			NDI (P)
			CFSAN_NDIThreshold_of_Regulation
			Threshold_of_Regulation
			CFSAN_TRESHOLD_OF_REGULATIONCTP
			
			Adverse_Events (A)
			CTP_AEElectronic_Submission
			Electronic_Submission
			CTP_ESUBCVM
			Adverse_Events_Reports
			Adverse_Events_Reports
			CVM_AERSeSubmitter
			eSubmitter
			CVM_ESUBMITTERManage Form
			Electronic_Submissions
			CVM_ESUBSCVM-VDD
			eSubmitter (T)
			eSubmitter (T)
			CVMVDD_eSubmitterGWTEST
			ConnectTest (T)
			ConnectTest (T)
			GWTEST_CONNECTIONSizeTest (T)
			SizeTest (T)
			GWTEST_7GBHC
			Transaction
			Transaction
			HC_TransactionMWP
			
			MWP_Report (A, NGP)
			MWP_REPORTOC
			SPL
			SPL
			OC_REGLIST_SPLOOPD
			HUD_Designation_Requests (T)
			HUD_Designation_Requests (T)
			OOPD_HUD_DESIGNATIONSOrphan_drug_Designation_Requests (T)
			Orphan_drug_Designation_Requests (T)
			OOPD_ORPHAN_DRUG_DESIGNATIONSOPQ
			704a4_Pharma_Inspection_Records (W)ORA
			Document_Requests (W)

                                                                                  Content current as of:
      01/12/2024About ESG

          
                        User Guide
          Account Management Portal User Guide
          Submission Statistics
          Impact of the Gateway
          Center Submission Types
          Submission Acknowledgements
          ESG Submission Process
          Planned Maintenance and Status History
          Submission Times
 
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