> For the complete documentation index, see [llms.txt](https://documentations.seclea.com/fda-ai-based-samd-risk-management/llms.txt). Markdown versions of documentation pages are available by appending `.md` to page URLs; this page is available as [Markdown](https://documentations.seclea.com/fda-ai-based-samd-risk-management/level-of-concern-document-lcd.md).

# Level of Concern Document (LCD)

When determining the risk posed by AI systems, several concerns pertaining to AI itself should be taken into consideration. These concerns should be tailored to the specifics of the system being evaluated as well as the environment in which it will be used. Organisations have a responsibility to make certain that the policies, processes, procedures, and practices related to mapping, measuring, and managing the risks associated with AI are in place, transparent, and successfully implemented.

Controls related to this risk category are listed as below:

* LCD 01 - Roles and Responsibilities 
* LCD 02 - Executive Responsibility 
* LCD 03 - AI Risk Organisational Practices 
* LCD 04 - Transparent Risk Management 
* LCD 05 - Risk Management Monitoring 
* LCD 06 - AI Risk Decisions Making 
* LCD 07 - AI Organisational Documentation 
* LCD 08 - Organisational Information Sharing Mechanism 
* LCD 09 - AI's Business Value 
* LCD 10 - Organisations AI Mission 
* LCD 11 - Organisations Risk Tolerance 
* LCD 12 - Allocated Resources for Risk Management 
* LCD 13 - 3rd Party Risk Policies 
* LCD 14 - 3rd Party Contingency 
* LCD 15 - Mapping 3rd-Party Risk 
* LCD 16 - Internal Risk Controls for 3rd Party Risk 
* LCD 17 - 3rd Party Risk are Managed 
* LCD 18 - AI Legal and Regulatory Requirements 
* LCD 19 - Stakeholder Assessment Consultation 
* LCD 20 - Risk Tracking and Management 
* LCD 21 - Risk Tracking Assessments 
* LCD 22 - Measurement Approaches for Identifying Risk 
* LCD 23 - Development and Deployment Decision 
* LCD 24 - Risk Mitigation Activities 
* LCD 25 - Risk Management of Mapped Risks 
* LCD 26 - Post-Deployment Risk Management


---

# Agent Instructions
This documentation is published with GitBook. GitBook is the documentation platform designed so that both humans and AI agents can read, navigate, and reason over technical content effectively. Learn more at gitbook.com.

## Querying This Documentation
If you need additional information that is not directly available in this page, you can query the documentation dynamically by asking a question.

Perform an HTTP GET request on the current page URL with the `ask` query parameter:

```
GET https://documentations.seclea.com/fda-ai-based-samd-risk-management/level-of-concern-document-lcd.md?ask=<question>
```

The question should be specific, self-contained, and written in natural language.
The response will contain a direct answer to the question and relevant excerpts and sources from the documentation.

Use this mechanism when the answer is not explicitly present in the current page, you need clarification or additional context, or you want to retrieve related documentation sections.