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title: "SAST and DAST, Definition | MedTech Terms"
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Cybersecurity [Connected & Cyber-Physical Devices](/ecosystems/connected-devices)

# SAST and DAST

Automated security testing - SAST analyzes source code at rest, DAST exercises a running application.

Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 

## Definition

Static Application Security Testing (SAST) analyzes source code, bytecode, or binaries without executing them, looking for known vulnerable patterns (SQL injection, buffer overflows, hardcoded secrets, insecure crypto). Dynamic Application Security Testing (DAST) probes a running application from the outside, exercising authenticated and unauthenticated paths to find runtime issues (auth bypass, injection, misconfiguration). Together they cover complementary parts of the OWASP testing surface and are baseline tooling for any modern CI/CD pipeline. 

What the regulation says

FDA's 2023 guidance expects security testing throughout development, with both static and dynamic analysis as standard components.  [NIST SP 800-218](/terms/ssdf) (SSDF) and  [IEC 81001-5-1](/terms/iec-81001-5-1) both include SAST/DAST in their lifecycle activity sets. The submission should describe which tools were used, what they covered, and how findings were dispositioned. 

## What this means in practice

SAST belongs in the developer's PR check (Semgrep, CodeQL, SonarQube, Checkmarx). DAST belongs in nightly or release-gate CI (OWASP ZAP, Burp Suite, Invicti). Both produce noise; mature teams tune rule sets, baseline known issues, and route real findings into the  [CAPA](/terms/capa) and security-fix workflow rather than dumping the raw tool output into the submission. 

Common pitfalls

-   • Submitting raw tool output without triage - reviewers cannot tell signal from noise. 
-   • Running SAST/DAST only at submission rather than continuously through the build pipeline. 
-   • Skipping SCA (Software Composition Analysis) - SAST finds your code's bugs, SCA finds your dependencies' bugs. 

## Frequently asked questions

Do we need both SAST and DAST? 

Yes - they find different classes of issues. SAST sees the whole codebase including unreachable paths; DAST sees what an attacker actually sees but only on exercised paths. 

What about IAST and SCA? 

Is fuzz testing the same as DAST? 

## Related terms

Grouped by theme 

### Editor's picks

· Hand-selected related concepts 

[

Cybersecurity

IEC 81001-5-1

International standard defining secure-product-lifecycle activities for health software, including medical devices.





](/terms/iec-81001-5-1)[

Cybersecurity

Penetration Testing

Hands-on adversarial testing in which qualified independent testers attempt to exploit a device's security controls.





](/terms/pen-test)[

Cybersecurity

Premarket Cybersecurity Submission

The bundle of cybersecurity artifacts a sponsor includes in a 510(k), De Novo, PMA, or HDE submission for a cyber device.





](/terms/premarket-cybersecurity)[

Cybersecurity

Section 524B of the FD&C Act(524B) 

The federal statute that gives FDA explicit premarket authority over cybersecurity for cyber devices.





](/terms/section-524b)

### More in Cybersecurity

· Same category 

[

Cybersecurity

Secure Product Development Framework(SPDF) 

A documented, risk-based set of processes that build cybersecurity into a medical device across its full lifecycle.





](/terms/spdf)[

Cybersecurity

AAMI SW96

AAMI/ANSI standard establishing requirements for medical-device cybersecurity activities throughout the lifecycle.





](/terms/aami-sw96)[

Cybersecurity

AAMI TIR57

AAMI Technical Information Report providing MedTech-specific guidance on cybersecurity risk management.





](/terms/aami-tir57)[

Cybersecurity

AAMI TIR97(TIR97) 

AAMI Technical Information Report on post-market security risk management for medical device manufacturers, the operational companion to TIR57.





](/terms/aami-tir97)

Cited by

Where this term appears across MedTech Terms.

Ecosystems (1)

-   [Connected & Cyber-Physical Devices](/ecosystems/connected-devices)

## Primary references

3 sources 

Link health:  3 verified · last checked 2026-06-20 

FDA· 1 NIST· 1 OWASP· 1 

1.  [1 
    
    FDA Cybersecurity Guidance (Sept 2023)
    
    Verified 
    
    FDA · fda.gov 
    
    
    
    ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-system-considerations-and-content-premarket-submissions)
2.  [2 
    
    NIST SP 800-218 (SSDF)
    
    Verified 
    
    NIST · csrc.nist.gov 
    
    
    
    ](https://csrc.nist.gov/publications/detail/sp/800-218/final)
3.  [3 
    
    OWASP ASVS
    
    Verified 
    
    OWASP · owasp.org 
    
    
    
    ](https://owasp.org/www-project-application-security-verification-standard/)

Inline markers like \[1\]  jump to the matching reference above.

Sponsor note

### Working on medical device cybersecurity?

Blue Goat Cyber specializes in MedTech cybersecurity - threat modeling, SBOMs, penetration testing, and FDA premarket submissions.

[Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session)

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MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor.

On this term

Category

Cybersecurity

Sources

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Updated

5/5/2026

[Compare with another term](/compare?a=sast-dast)

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Card Lesson Quiz

Automated security testing - SAST analyzes source code at rest, DAST exercises a running application.

-   · SAST belongs in the developer's PR check (Semgrep, CodeQL, SonarQube, Checkmarx). 
-   · DAST belongs in nightly or release-gate CI (OWASP ZAP, Burp Suite, Invicti). 
-   · Both produce noise; mature teams tune rule sets, baseline known issues, and route real findings into the CAPA and security-fix workflow rather than dumping the raw tool output into the submission. 

Remember this

Watch out: Submitting raw tool output without triage - reviewers cannot tell signal from noise.

Related terms

-   [Penetration Testing ](/terms/pen-test)
-   [Premarket Cybersecurity Submission ](/terms/premarket-cybersecurity)
-   [Secure Product Development Framework(SPDF) ](/terms/spdf)
-   [Section 524B of the FD&C Act(524B) ](/terms/section-524b)
-   [IEC 81001-5-1 ](/terms/iec-81001-5-1)

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