CDRH Event Problem Codes |
Requesting a New CodeThe process for requesting a new code has changed. The process to request a new code follows: Step 1: Contact the Change Control Board (CCB) to obtain a code request form:
Step 2: The CDRH Event Problem 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 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 website. Updated April 2, 2009 |
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