This website covers information about the manufacturer evaluation codes that can be used to complete medical device reports. The event problem codes consist of patient problem codes, device problem codes, and component codes. If you are looking for event problem codes, you can find them in the Event Problem Codes page.
SPECIAL NOTE ABOUT CODES FOR MEDICAL DEVICE REPORTS (MDRs) : Please remember that only FDA-authorized codes will be accepted in mandatory MDRs for CDRH. While some CDRH codes may also appear in other coding structures, the best way to assure that you are using an FDA-authorized code is to check the codes lists provided here.
The Food and Drug Administration Center for Devices and Radiological Health (FDA CDRH), in cooperation with the National Cancer Institute Enterprise Vocabulary Service (NCI-EVS) completed a manufacturer evaluation vocabulary effort that updated the older CDRH Manufacturer Evaluation Codes (Method, Result, and Conclusions, reference Block H6 of FDA Form 3500A). This update was needed for the following reasons:
- Majority of codes did not allow for detailed explanations of the evaluation (resulting in much of the evaluation being described in the manufacturer narrative)
- No change control procedures to manage the addition, deletion or update of terms
- No on-line access method that assisted with automated downloading of current terms
The CDRH Manufacturer Evaluation Code initiative has:
- Reviewed the existing Manufacturer Evaluation Codes
- Updated these codes to reduce manufacturer reporting burden, improve adverse event report quality, and improve FDA’s ability to respond to device-related adverse events
- Used this website to store the updated codes and tools for aiding the transition from the current to the enhanced coding system
How has this initiative improved the CDRH Manufacturer Evaluation Codes?
The original coding system had not undergone systematic review since its original inception and did not include mechanisms to promote ongoing quality improvement. The FDA CDRH/NCI EVS collaboration provided the resources to perform a systematic review of the current codes that resulted in improvements to the coding system with minimal burden to reporters, including:
- Specific improvements to the method, result, and conclusion codes
- Improvements to code descriptions, definitions and structure to improve the effectiveness of the terms for identifying safety signals
Under the new coding system, CDRH has designated a preferred term that represents a unique evaluation method, result, or conclusion concept. By having just one term represent an evaluation concept, the reporter should be able to more easily select an appropriate code. The reporter will also be able to review the definition that has been included for many codes as well as considering code selection within the context of a meaningful hierarchy. Note: the definitions assigned to the Manufacturer Evaluation Codes are not regulatory definitions. They have been added to many Manufacturer Evaluation Code terms to provide additional clarification. The focus of the FDA CDRH/NCI EVS collaboration was on creating the Manufacturer Evaluation Code set as a self-contained hierarchy developed specifically to address all categories of manufacturer evaluation. Currently, the manufacturer evaluation codes are arranged in a hierarchy. We recommend that coders assign terms at the lowest level of the hierarchy.
The focus of the FDA CDRH/NCI EVS collaboration was on creating the Manufacturer Evaluation Code set as a self-contained hierarchy developed specifically to address all categories of manufacturer evaluation. Currently, the manufacturer evaluation codes are arranged in a hierarchy. We recommend that coders assign terms at the lowest level of the hierarchy.
- Creation of educational tools to increase the likelihood of improved code use
- Adoption of change control mechanisms to maintain coding improvements and ensure ongoing improvement in coding quality for the future
- Outreach to terminology groups to promote harmonization of event problem code terminology
As part of the initiative the FDA CDRH staff has and will continue to promote the use of the manufacturer evaluation codes as a controlled terminology for describing a manufacturers evaluation of a device that can be used in both regulatory and non-regulatory environments. FDA worked collaboratively with standards groups in the development of the codes and will continue to work with these groups using our change control processes.
Each FDA term now includes not only an FDA code (which should still be the preferred code added to the FDA form 3500A), but a unique NCI EVS Concept code (c-code) that allows the term to be used for any problem reporting situation. FDA is actively promoting the use of the new hierarchal code system not only for FDA Form 3500A, but in any situation involving reporting of device-related adverse events including HL7 ICSR standard, premarket studies where device event data is captured, condition of approval studies, and patient safety reporting from research groups.
- Minimize burden to manufacturers
Many of the manufacturer evaluation codes in the current system were retained in the new system, with the added ability to further describe the details of the evaluation using the new terms.