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 |