Center Submission Types
| Column Definitions: | |
|---|---|
| Test Submission Available: Indicates which Center/Submission Types allow test submissions. | |
| Production Submission Available: Indicates which Center/Submission Types allow production submissions | |
| File Size Threshold (GB): Provides the Center’s guidance on the Center/Submission Type file size supported. While ESG NextGen supports submissions up to 1TB, Center’s have set their own file size thresholds. | |
| Test Submission Required for New ESG NextGen Users: Indicates which Center/Submission Types require a test submission prior to allowing a new user to submit a production submission. If a test submission is not required by a Center/Submission Type, upon approval of the new users account, the new user will be able to submit both test and production submissions for that Center/Submission Type. This applies to submitters creating an account with ESG for the very first time. | |
Notes: 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’. CDRH Premarket submission should be sent via the CDRH Customer Collaboration Portal. |
| Center | Submission Type | Test (T) / Production (P) / Both (B) Submission Available | File Size Threshold (GB) | Test Submission Required for New ESG NextGen Users |
| CBER | 510K | B | 200 | Y |
| AERS | B | 0.2 | Y | |
| AERS Attachments | B | 0.2 | Y | |
| AERS_PREMKT_CBER | B | 0.2 | Y | |
| AERS_ATTACHMENTS_PREMKT_CBER | B | 0.2 | Y | |
| EBLA | B | 200 | Y | |
| eDMF | B | 200 | Y | |
| EIDE | B | 200 | Y | |
| EIND | B | 200 | Y | |
| EUA | B | 200 | Y | |
| Lot_Release_Protocol | B | 200 | N | |
| NDA | B | 200 | N | |
| PMA | B | 200 | Y | |
| Pre_IND | B | 200 | Y | |
| Promotional_Materials | B | 200 | N | |
| QSUBS | B | 200 | Y | |
| SEND_PILOT | T | 200 | N | |
| SPL_LDD | B | 200 | Y | |
| VAERS | B | 200 | Y | |
| CDER | ACA6004_Drug_Samples | B | 2 | N |
| AERS | B | 0.2 | Y | |
| AERS Attachments | B | 0.2 | Y | |
| AERS IND | T | 0.2 | N | |
| AERS Attachment IND | T | 0.2 | N | |
| AERS_PREMKT | T | 0.2 | N | |
| AERS_Attachments_PREMKT | T | 0.2 | N | |
| AERS_PREMKT_CDER | B | 0.2 | Y | |
| AERS_ATTACHMENTS_PREMKT_CDER | B | 0.2 | N | |
| ECTD | B | 300 | N | |
| ECTD WAIVED | B | 300 | N | |
| EDMF TYPEIII | B | 100 | N | |
| EIND | B | 100 | N | |
| FFU-PILOT | T | 100 | N | |
| GDUFA_Facility_Registration | B | 0.005 | N | |
| PFC | B | 100 | N | |
| POR Large Molecule Documents | B | 100 | N | |
| Voluntary_Direct_Aes | B | 0.2 | N | |
| CDRH | Adverse Events | B | 100 | N |
| Electronic_Submissions | B | 100 | Y | |
| GUDID | B | 100 | Y | |
| HFP (formerly CFSAN) | DSR_Adverse_Events | B | 0.3 | N |
| EON-Payload-Files | P | 0.3 | N | |
| Food_Pilot_Listing | P | 0.3 | N | |
| Form3479 | B | 0.3 | Y | |
| Form3480 | B | 0.3 | Y | |
| Form3480A | B | 0.3 | Y | |
| Form3503 | B | 0.3 | Y | |
| Form3665 | B | 0.3 | Y | |
| Form3666 | B | 0.3 | Y | |
| Form3667 | B | 0.3 | Y | |
| NDI | P | 0.3 | N | |
| Threshold_of_Regulation | B | 0.3 | Y | |
| CTP | Adverse_Events | B | 100 | Y |
| Electronic_Submission | B | 100 | Y | |
| CVM | Adverse_Events_Reports | B | 1 | N |
| eSubmitter | B | 1 | N | |
| GWTEST | ConnectTest | T | 100 | N |
| SizeTest | T | 100 | N | |
| HealthCanada | Transaction | B | 10 | N |
| OC | SPL | B | 100 | N |
| OCAC | B | 0.2 | Y | |
| OOPD | HUD_Designation_Requests | T | 100 | N |
| Orphan_drug_Designation_Requests | T | 100 | N | |
| OPQ | 704a4_Pharma_Inspection_Records | B | 100 | N |
| OII | Document_Requests | B | 100 | N |
| POR Small Molecule Documents | B | 100 | N |
| Column Definitions: | |
|---|---|
| USP and API Submission Type: Provides the submission types supported by USP and API submissions. | |
| AS2 Submission Type and AS2 Routing ID: Provides the header information needed when submitting via AS2. If the AS2 Submission Type and AS2 Routing ID columns are blank, then these Center/Submission Types are not supported by AS2. |
| Center | USP and API Submission Type | AS2 Submission Type | AS2 Routing ID |
| CBER | 510K | 510K | CBER_510K |
| AERS | AERS | FDA_AERS | |
| AERS Attachments | AERS_ATTACHMENTS | FDA_AERS_ATTACHMENTS | |
| AERS_PREMKT_CBER | AERS_PREMKT_CBER | FDA_AERS_PREMKT_CBER | |
| AERS_ATTACHMENTS_PREMKT_CBER | AERS_ATTACHMENTS_PREMKT_CBER | FDA_AERS_ATTACHMENTS_PREMKT_CBER | |
| EBLA | EBLA | CBER_EBLA | |
| eDMF | eDMF | CBER_EDMF | |
| EIDE | EIDE | CBER_EIDE | |
| EIND | EIND | CBER_EIND | |
| EUA | EUA | CBER_EUA | |
| Lot_Release_Protocol | Lot_Release_Protocol | CBER_LOT_RELEASE_PROTOCOL | |
| NDA | NDA | CBER_NDA | |
| PMA | PMA | CBER_PMA | |
| Pre_IND | PRE_IND | CBER_PRE_IND | |
| Promotional_Materials | Promotional_Materials | CBER_PROMOTIONAL_MATERIAL | |
| QSUBS | QSUBS | CBER_QSUBS | |
| SEND_PILOT | SEND_PILOT | CBER_SEND_PILOT | |
| SPL_LDD | SPL_LDD | CBER_SPLLD | |
| VAERS | VAERS | CBER_VAERS | |
| CDER | ACA6004_Drug_Samples | ACA6004_Drug_Samples | CDER_ACA6004 |
| AERS | AERS | FDA_AERS | |
| AERS Attachments | AERS_ATTACHMENTS | FDA_AERS_ATTACHMENTS | |
| AERS IND | AERS_IND | AERS_IND | |
| AERS Attachment IND | AERS_ATTACHMENTS_IND | AERS_ATTACHMENTS_IND | |
| AERS_PREMKT | AERS_PREMKT | FDA_AERS_PREMKT | |
| AERS_Attachments_PREMKT | AERS_Attachments_PREMKT | FDA_AERS_ATTACHMENTS_PREMKT | |
| AERS_PREMKT_CDER | AERS_PREMKT_CDER | FDA_AERS_PREMKT_CDER | |
| AERS_ATTACHMENTS_PREMKT_CDER | AERS_ATTACHMENTS_PREMKT_CDER | FDA_AERS_ATTACHMENTS_PREMKT_CDER | |
| ECTD | ECTD | CDER_ECTD | |
| ECTD WAIVED | ECTD_WAIVED | CDER_ECTD_WAIVED | |
| EDMF TYPEIII | EDMF_TYPEIII | CDER_EDMF_TYPEIII | |
| EIND | EIND | CDER_EIND | |
| FFU-PILOT | FFU-PILOT | CDER_FFU-PILOT | |
| GDUFA_Facility_Registration | GDUFA_Facility_Registration | CDER_GDUFA_FACILITY_REGISTRATION | |
| PFC | PFC | CDER_PFC | |
| POR Large Molecule Documents | POR_Large_Molecule_Docs | CDER_POR_Large_Molecule_Docs | |
| Voluntary_Direct_Aes | |||
| CDRH | Adverse Events | Adverse_Events | CDRH_AERS |
| Electronic_Submissions | Electronic_Submissions | CDRH_ESUBS | |
| GUDID | GUDID | CDRH_GUDID | |
| HFP (formerly CFSAN) | DSR_Adverse_Events | DSR_Adverse_Events | CFSAN_DRG_ADVERSE_EVENTS |
| EON-Payload-Files | EON-Payload-Files | CFSAN_EON_PAYLOAD_FILES | |
| Food_Pilot_Listing | Food_Pilot_Listing | CFSAN_FOOD_PILOT_LISTING | |
| Form3479 | Form3479 | CFSAN_Form3479 | |
| Form3480 | Form3480 | CFSAN_FORM3480 | |
| Form3480A | Form3480A | CFSAN_FORM3480A | |
| Form3503 | Form3503 | CFSAN_FORM3503 | |
| Form3665 | Form3665 | CFSAN_FORM3665 | |
| Form3666 | Form3666 | CFSAN_FORM3666 | |
| Form3667 | Form3667 | CFSAN_FORM3667 | |
| NDI | NDI | CFSAN_NDI | |
| Threshold_of_Regulation | Threshold_of_Regulation | CFSAN_THRESHOLD_OF_REGULATION | |
| CTP | Adverse_Events | Adverse_Events | CTP_AE |
| Electronic_Submission | Electronic_Submission | CTP_ESUB | |
| CVM | Adverse_Events_Reports | Adverse_Events_Reports | CVM_AERS |
| eSubmitter | eSubmitter | CVM_ESUBMITTER | |
| GWTEST | ConnectTest | ConnectTest | GWTEST_CONNECTION |
| SizeTest | SizeTest | GWTEST_7GB | |
| HealthCanada | Transaction | Transaction | HC_Transaction |
| OC | SPL | SPL | OC_REGLIST_SPL |
| OCAC | OCAC | AERS_PSTMKT_OCAC | |
| OOPD | HUD_Designation_Requests | HUD_Designation_Requests | OOPD_HUD_DESIGNATIONS |
| Orphan_drug_Designation_Requests | Orphan_drug_Designation_Requests | OOPD_ORPHAN_DRUG_DESIGNATIONS | |
| OPQ | 704a4_Pharma_Inspection_Records | ||
| OII | Document_Requests | ||
| POR Small Molecule Documents | POR_Small_Molecule_Docs | ORA_POR_Small_Molecule_Docs |