The process to request a new code follows the below steps:
Step 1: Contact the Change Control Board (CCB) to obtain a code request form:
Step 2: The CDRH Event Problem/Evaluation Code CCB will review new requests and establishes priorities based on documented rationale for the new code. Routine requests will be reviewed, on average, once a month.
Step 3: The CDRH Event Problem/Evaluation Code CCB will provide documentation and justification when a proposed code is authorized or vetoed. CCB will notify the requestor whether a proposed code is authorized or vetoed or if there are any questions about the request. Therefore, it is very important to include contact information in your request.
Step 4: If authorized, the new code will be added to both the NCI Thesaurus and to the appropriate code hierarchy in MAUDE
Step 5: All stakeholders will be alerted to the existence of new codes via a subscription to the FDA CDRH Event Problem Code mailing list.