Medical Devices

Manufacturer Evaluation Codes: Requesting a New Code

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:

Phone: 301-796-6670

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.

Page Last Updated: 11/28/2016
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