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U.S. Department of Health and Human Services

Medical Devices

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Submitting Manufacturer Evaluation Codes

Submitters are able to use one of the following methods of Medical Device Report Submission to submit evaluation codes:

Paper version of 3500A Form

Note: Only use FDA codes for paper submissions

Evaluation Codes

1. Select the lowest-level (i.e. most detailed) code(s) from the code list that describes the evaluation of a device. The topmost level of the hierarchy will not be accepted as a valid code. See Evaluation Code resource files to aid in evaluation method code selection:

  • CDRH has developed the Event Problem and Evaluation Code terminology for reporting of medical device problems. Six CDRH term sets, covering Patient Problem Codes, Device Problem Codes, Device Component Codes, Evaluation Method Codes, Evaluation Result Codes, and Evaluation Conclusion Codes are maintained in NCIt (as both NCI Concept Codes (C-Codes) and FDA codes) and available for download in Excel, XML, and Text formats for importing into other applications.
  • CDRH Evaluation Codes Disposition - An Excel file that lists all the old FDA CDRH Evaluation Codes and terms (organized alphabetically) separated by the code type (method, result, conclusion) and maps to the improved Evaluation Codes. The file shows exactly what happened to each code and provides recommendations for selection of the improved term. The file also indicates which terms were inactivated as part of this project.
  • Code Hierarchies – organizes the evaluation codes as a hierarchical listing:
    • Evaluation Method Codes
    • Evaluation Result Codes
    • Evaluation Conclusion Codes

2. Enter the 2 to 4-digit FDA Evaluation Method, Evaluation Result, or Evaluation Conclusion Code number in section H6 in the box labeled “Method”, “Results”, or “Conclusions” respectively. Select as many Evaluation Codes as appropriate for each type of evaluation code. The 3500A form allows entry of 3 codes for each code type in Section H6. Feel free to record additional codes on a separate sheet, mark it "H6", and provide the report number and page number, or by inserting additional codes in the H10 Block on the 3500A form.

Component Code (Optional)

3. Component Codes can be associated with the Evaluation Result Codes by entering the 3 or 4 digit FDA Component Code in the box labeled ‘Results’. These components can be found as new Component Codes for entry on MedWatch Form 3500A, or listed with the Evaluation Results Codes for section H.6. Component Codes are not required, but can be used to further describe a result of an evaluation selected in the Evaluation Result Code. Do not submit a Component Code without an Evaluation Result Code.

Note: the component codes listed in each of these sections are now exactly the same and can be used to report component information in either F.10 or H.6 of the MedWatch 3500A Form. To see what has changed, please see the Component disposition file which includes FDA code # changes, new codes, as well as inactivated codes.

Electronic submission using HL7 ICSR

Please use the following instructions for entering each of the three CDRH Evaluation Codes using the HL7 ICSR messaging format:

1. Select the lowest-level (i.e. most detailed) code(s) from the code list that describes the evaluation of a device. The topmost level of the hierarchy will not be accepted as a valid code. See Evaluation Code resource files to aid in evaluation method code selection:

  • CDRH has developed the Event Problem and Evaluation Code terminology for reporting of medical device problems. Six CDRH term sets, covering Patient Problem Codes, Device Problem Codes, Device Component Codes, Evaluation Method Codes, Evaluation Result Codes, and Evaluation Conclusion Codes are maintained in NCIt (as both NCI Concept Codes (C-Codes) and FDA codes) and available for download in Excel, XML, and Text formats for importing into other applications.
  • CDRH Evaluation Codes Disposition - An Excel file that lists all the old FDA CDRH Evaluation Codes and terms (organized alphabetically) separated by the code type (method, result, conclusion) and maps to the improved Evaluation Codes. The file shows exactly what happened to each code and provides recommendations for selection of the improved term. The file also indicates which terms were inactivated as part of this project.
  • Code Hierarchies – organizes the evaluation codes as a hierarchical listing:
    • Evaluation Method Codes
    • Evaluation Result Codes
    • Evaluation Conclusion Codes

2. Until further notice, electronic submitters may choose to submit Evaluation Codes using either the FDA or C-codes. Eventually the C-codes will replace the current FDA-assigned code to facilitate Evaluation Code adoption as evaluation terminology by a variety of organizations.

3. Use HL7 ICSR messaging format to transmit the selected codes.

A. Below is the original HL7 ICSR coding to represent selection of the Evaluation Method Code FDA 10; C91896 – actual device evaluated:

<component3>
<evaluationMethod>
<code code="C53984" codeSystemName="Evaluation_Method_Code" />
<value xsi:type="CE" code="10" />
</evaluationMethod>
</component3>

The following shows the changes required to represent selection in the enhanced coding system. Specifically, FDA code 10 replaced with the associated NCI code – C91896:

<component3>
<evaluationMethod>
<code code="C53984" codeSystemName="Evaluation_Method_Code" />
<value xsi:type="CE" code="C91896" />
</evaluationMethod>
</component3>

B. Below is the original HL7 ICSR coding to represent selection of the Evaluation Result Code FDA 102; C92066 – incompatible component:

<component1>
<evaluationResult>
<code code="C53985" codeSystemName="Evaluation_Result_Code" />
<value xsi:type="CE" code="102" />
</evaluationResult>
</component1>

The following shows the changes required to represent selection in the enhanced coding system. Specifically, FDA code 102 replaced with the associated NCI code – C92066:

<component1>
<evaluationResult>
<code code="C53985" codeSystemName="Evaluation_Result_Code" />
<value xsi:type="CE" code="C92066" />
</evaluationResult>
</component1>

C. Below is the original HL7 ICSR coding to represent selection of the Evaluation Conclusion Code FDA 50; C91872 – device failure related to patient condition:

<component2>
<evaluationConclusion>
<code code="C53984" codeSystemName="Evaluation_Conclusion_Code" />
<value xsi:type="CE" code="50" />
</evaluationConclusion>
</component2>

The following shows the changes required to represent selection in the enhanced coding system. Specifically, FDA code 50 replaced with the associated NCI code – C91872:

<component2>
<evaluationConclusion>
<code code="C53984" codeSystemName="Evaluation_Conclusion_Code" />
<value xsi:type="CE" code="C91872" />
</evaluationConclusion>
</component2>

4. Repeat the above segments of code for all selected codes. There is no upper limit to the number of CDRH Event Problem Codes that can be assigned.

Component Code (Optional)

5. Component Codes can be associated with the Evaluation Result Codes. These components can be found as new Component Codes for entry on MedWatch Form 3500A, or listed with the Evaluation Results Codes for section H.6. Component Codes are not required, but can be used to further describe a result of an evaluation selected in the Evaluation Result Code. Do not submit a Component Code without an Evaluation Result Code.

Note: the component codes listed in each of these sections are now exactly the same and can be used to report component information in either F.10 or H.6 of the MedWatch 3500A Form. To see what has changed, please see the Component disposition file which includes FDA code # changes, new codes, as well as inactivated codes.

Use the same XML HL7 ICSR segment as used for the Evaluation Result Code. Future releases of the HL7 ICSR will have a separate tag for component, but this is not currently available. See example for coding Electrical Lead – FDA 452; C50027:

<component1>
<evaluationResult>
<code code="C53985" codeSystemName="Evaluation_Result_Code" />
<value xsi:type="CE" code="452" />
</evaluationResult>
</component1>

The following shows the changes required to represent selection in the enhanced coding system. Specifically, FDA code 452 replaced with the associated NCI code – C50027:

<component1>
<evaluationResult>
<code code="C53985" codeSystemName="Evaluation_Result_Code" />
<value xsi:type="CE" code="C50027" />
</evaluationResult>
</component1>

For further details about the HL7 ICSR and for submitting all vocabulary items using HL7 ICSR, please refer to the CDRH Electronic Reporting website

eSubmitter

1. For each of the Evaluation Codes (“Method”, “Results”, and “Conclusions”), use the Filter Dialog screen to enter a term into the search field to pull all relevant codes. The system should return evaluation codes for the section codes are being entered into. Select the most appropriate code. (Note: If you need further assistance in selecting a code, see the Evaluation Code resource files to view or download the Evaluation Codes, Evaluation Code definitions, and files showing a mapping between FDA and NCI concept codes.)

  • CDRH has developed the Event Problem and Evaluation Code terminology for reporting of medical device problems. Six CDRH term sets, covering Patient Problem Codes, Device Problem Codes, Device Component Codes, Evaluation Method Codes, Evaluation Result Codes, and Evaluation Conclusion Codes are maintained in NCIt (as both NCI Concept Codes (C-Codes) and FDA codes) and available for download in Excel, XML, and Text formats for importing into other applications.
  • CDRH Evaluation Codes Disposition - An Excel file that lists all the old FDA CDRH Evaluation Codes and terms (organized alphabetically) separated by the code type (method, result, conclusion) and maps to the improved Evaluation Codes. The file shows exactly what happened to each code and provides recommendations for selection of the improved term. The file also indicates which terms were inactivated as part of this project.
  • Code Hierarchies – organizes the evaluation codes as a hierarchical listing:
    • Evaluation Method Codes
    • Evaluation Result Codes
  • Evaluation Conclusion Codes

2. If you wish to add more Evaluation Codes, repeat step 1.

3. The system will store your code selection(s) and your information will be transmitted electronically via an HL7 ICSR message when you submit the eSubmitter-created package and send it through the Electronic Submissions Gateway.

Component Code (Optional)

Component Codes can be associated with the Evaluation Result Codes. These components can be found as new Component Codes for entry on MedWatch Form 3500A, Field F.10 or listed with the Evaluation Results Codes for section H.6. Component Codes are not required, but can be used to further describe a result of an evaluation selected in the Evaluation Result Code. Do not submit a Component Code without an Evaluation Result Code.

Note: the component codes listed in each of these sections are now exactly the same and can be used to report component information in either F.10 or H.6 of the MedWatch 3500A Form. To see what has changed, please see the Component disposition file which includes FDA code # changes, new codes, as well as inactivated codes.

2. If you wish to add more Component Codes, select ‘Add another code’ in the Evaluation Results Code section and repeat step 1. There is no limit to the number of Component Codes that can be selected.

3. The system will store your code selection(s) and your information will be transmitted electronically via an HL7 ICSR message when you submit the eSubmitter-created package and send it through the Electronic Submissions Gateway.

For Further details about the eSubmitter application and for submitting adverse event reports using that electronic option, please refer to the FDA eSubmitter.