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CDER DATA STANDARDS MANUAL |
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CDER DATA STANDARDS MANUAL |
FDA Data Element Number.
CDER Data Element Number. C-GEN-10207
Data Element Name. Application Type
Description. Application Type is the primary category of official submission that is received by the Center.
Source. Various Oracle tables, including COMIS Reference Table.
Relationship. See Application Number.
FDA Specifications. None.
CDER Specifications. Application Type is represented by alphanumeric text of one character in length.
FDA Approved Date.
CDER Approved Date. March 14, 1995
FDA Revised Date.
CDER Revised Date.
Data Values.
| NAME | DEFINITION | FDA CODE |
|---|---|---|
| Device Classification 513(G) (CDRH) | C | |
| New Device Application in Form 5's and Form 6's (CDRH) | F | |
| Premarket Notification Submission 510(K) | K | |
| Product Development Protocol | Z | |
| Reclassification Petition | R | |
| Drug Master File | D | |
| Investigational Device Exemption 520(G) (CDRH) | G | |
| Investigational Device Exemption 520(L) | L | |
| Investigational New Drug Exemption (CBER) | B | |
| Investigational New Drug Exemption (CDER) | I | |
| New Drug Application (CBER) | X | |
| New Drug Application (CDER) | N | |
| Premarket Approval Application | P |