> For the complete documentation index, see [llms.txt](https://docs.medcrypt.com/llms.txt). Markdown versions of documentation pages are available by appending `.md` to page URLs; this page is available as [Markdown](https://docs.medcrypt.com/msi/check-estar-readiness.md).

# Prepare your submission

FDA eSTAR Readiness checks your documentation against the cybersecurity requirements in the FDA's eSTAR, the electronic template used for premarket submissions. It flags each requirement as covered, partially covered, or missing, with evidence traced back to your documents, so you know what's ready and what's still needed before you file.

## Before you begin

* Your organization's plan must include eSTAR Readiness.
* Select the device and device version you're preparing to submit, and upload its documents.
* Check the version's device modification status. It decides which eSTAR sections are required and is set when you configure the device version:

| Device modification status                   | Required eSTAR sections |
| -------------------------------------------- | ----------------------- |
| **Yes, cybersecurity is unaffected**         | 3                       |
| **No, device was not previously authorized** | 11                      |
| **No, cybersecurity is affected**            | 11                      |

A previously authorized device is, for example, one cleared through a 510(k), granted through a De Novo, or approved through a PMA. Changes to authentication or encryption, new connectivity, or a new software update mechanism usually affect cybersecurity. Changes to materials or sterilization usually don't.

## Start a readiness check

1. In the sidebar, select **FDA eSTAR Readiness**. If the selected version has no readiness check yet, you see the start form with the version's **Device Modification Status** and an estimated run time.
2. Select **Start**.

The first step, the document coverage check, runs right away. To start another check later, use the selector in the page header and select **+ New Checklist**.

## Work through the three steps

A readiness check moves through three steps. The progress bar at the top shows where you are, and you can select a step to switch to it.

1. **Document Coverage Check**: checks whether your documents contain evidence for each eSTAR category. Full coverage doesn't guarantee you'll pass the FDA's technical screening, so the next step looks at quality.
2. **Quality Check**: checks whether the evidence you have is good enough to meet the FDA's content requirements. Select **Run Quality Review** to start it. If quality results already exist, you're asked whether to rerun; rerunning replaces them.
3. **Medcrypt Review**: a Medcrypt expert reviews your checklist. Select **Submit for MedCrypt Review**. You're notified when the review is complete.

{% hint style="info" %}
Steps marked **Pro** aren't included in your current plan. On free plans, only the Document Coverage Check is available. During a trial, the Medcrypt Review step isn't available.
{% endhint %}

{% hint style="warning" %}
Switching away from the Medcrypt Review step while a review is in progress withdraws your checklist from review, and any progress Medcrypt's reviewers made is lost.
{% endhint %}

## Understand the results

The gauge shows how many requirements are covered, partially covered, or missing for the current step.

The requirements table lists each **FDA eSTAR Category** with its **Fulfilled** status:

| Status                  | Meaning                                                             |
| ----------------------- | ------------------------------------------------------------------- |
| **Fulfilled**           | Your documents address the requirement.                             |
| **Partially Fulfilled** | Some evidence exists, but it doesn't fully address the requirement. |
| **Not fulfilled**       | No evidence was found.                                              |

Rows marked **Review needed** need a person to confirm the result. Focus first on partially fulfilled and not fulfilled rows.

## Review evidence and add notes

1. Expand a row to see the individual checks under that category. Each shows the **Requirement**, whether it **Fulfills Requirement** (**Yes**, **No**, or **N/A**), the **Evidence**, and **Notes**.
2. To change a result, select a different value in **Fulfills Requirement**.
3. To attach evidence, select a document in the **Evidence** column. You can also point to an **Evidence Location** in that document.
4. Add context for reviewers in **Notes**.

To open the device's documents, select **Device Documents** in the header.

## Get help from Medcrypt

1. Select the checkboxes on the categories you need help with.
2. Select **Request MedCrypt Help**.

Someone from Medcrypt reaches out to you by email.

## Track changes and export

* Select **Audit Log** to see every change to the checklist. Filter by event type, such as **Status & Evidence**, **Documents**, or **Notes**, and by date range.
* Select **Export OSCAL** to download machine-readable OSCAL 1.1.2 files: **System Security Plan**, **Assessment Results**, or **Plan of Action & Milestones**. OSCAL is a NIST standard format for security assessment data that other tools can read.

## Next steps

* [Find and close compliance gaps](/msi/check-estar-readiness/find-and-close-compliance-gaps.md): track documentation gaps and respond to FDA requests for more information.
* [Generate submission documents](/msi/check-estar-readiness/generate-submission-documents.md): produce the documents your checklist calls for.
* [Run a regulatory audit](/msi/check-estar-readiness/run-a-regulatory-audit.md): get a simulated reviewer's view of your documentation.