Center Submission Types
FDA ESG Center Submission Types (PDF)
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. |
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 ID |
---|---|---|---|
CBER | 510K | 510K | CBER_510K |
AERS | AERS | FDA_AERS | |
AERS Attachments | AERS_ATTACHMENTS | FDA_AERS_ATTACHMENTS | |
AERS_PREMKT_CBER (T) | AERS_PREMKT_CBER (T) | FDA_AERS_PREMKT_CBER | |
AERS_ATTACHMENTS_PREMKT_CBER (T) | AERS_ATTACHMENTS_PREMKT_CBER (T) | FDA_AERS_ATTACHMENTS_PREMKT_CBER | |
BEST | BEST | CBER_BEST | |
CDISC | CDISC | CBER_CDISC | |
EBLA | EBLA | CBER_EBLA | |
eDMF | eDMF | CBER_EDMF | |
EIDE | EIDE | CBER_EIDE | |
EIND | EIND | CBER_EIND | |
EUA | EUA | CBER_EUA | |
H1N1_Lot_Release (A) | CBER_H1N1_LOT_RELEASE | ||
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 (T) | SEND_PILOT (T) | 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 (T) | AERS_IND (T) | AERS_IND | |
AERS Attachment IND (T) | AERS_ATTACHMENTS_IND (T) | AERS_ATTACHMENTS_IND | |
AERS_PREMKT (T) | AERS_PREMKT (T) | FDA_AERS_PREMKT | |
AERS_Attachments_PREMKT (T) | AERS_Attachments_PREMKT (T) | FDA_AERS_ATTACHMENTS_PREMKT | |
AERS_PREMKT_CDER (T) | AERS_PREMKT_CDER (T) | FDA_AERS_PREMKT_CDER | |
AERS_Attachments_PREMKT_CDER (T) | AERS_Attachments_PREMKT_CDER (T) | 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 (T) | FFU-PILOT (T) | CDER_FFU-PILOT | |
GDUFA_Facility_Registration | GDUFA_Facility_Registration | CDER_GDUFA_FACILITY_REGISTRATION | |
PFC | PFC | CDER_PFC | |
Voluntary_Direct_AEs (W) | |||
CDRH | Adverse Events | Adverse_Events | CDRH_AERS |
Electronic_Submissions | Electronic_Submissions | CDRH_ESUBS | |
GUDID | GUDID | CDRH_GUDID | |
CFSAN | DSR_Adverse_Events (A) | CFSAN_DSR_ADVERSE_EVENTS | |
EON-Payload-Files (P) | EON-Payload-Files (P) | CFSAN_EON_PAYLOAD_FILES | |
Food_Pilot_Listing (P) | Food_Pilot_Listing (P) | 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 (P) | NDI (P) | CFSAN_NDI | |
Threshold_of_Regulation | Threshold_of_Regulation | CFSAN_TRESHOLD_OF_REGULATION | |
CTP | Adverse_Events (A) | CTP_AE | |
Electronic_Submission | Electronic_Submission | CTP_ESUB | |
CVM | Adverse_Events_Reports | Adverse_Events_Reports | CVM_AERS |
eSubmitter | eSubmitter | CVM_ESUBMITTER | |
Manage Form | Electronic_Submissions | CVM_ESUBS | |
CVM-VDD | eSubmitter (T) | eSubmitter (T) | CVMVDD_eSubmitter |
GWTEST | ConnectTest (T) | ConnectTest (T) | GWTEST_CONNECTION |
SizeTest (T) | SizeTest (T) | GWTEST_7GB | |
HC | Transaction | Transaction | HC_Transaction |
MWP | MWP_Report (A, NGP) | MWP_REPORT | |
OC | SPL | SPL | OC_REGLIST_SPL |
OOPD | HUD_Designation_Requests (T) | HUD_Designation_Requests (T) | OOPD_HUD_DESIGNATIONS |
Orphan_drug_Designation_Requests (T) | Orphan_drug_Designation_Requests (T) | OOPD_ORPHAN_DRUG_DESIGNATIONS | |
OPQ | 704a4_Pharma_Inspection_Records (W) | ||
ORA | Document_Requests (W) |