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

# Coordinated Vulnerability Disclosure

A documented process for receiving, triaging, and responsibly disclosing security vulnerabilities reported by external researchers.

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

## Definition

Coordinated Vulnerability Disclosure (CVD) is the documented process by which a manufacturer accepts vulnerability reports from external researchers, validates and remediates the issues, and publishes advisories - coordinated to give operators time to deploy fixes before attackers exploit them. ISO/IEC 29147:2018 defines the disclosure process and ISO/IEC 30111:2019 defines the internal handling process. FDA, CISA, and ENISA all expect MedTech manufacturers to operate a CVD program. 

What the regulation says

FDA's 2023 guidance and section  [524B](/terms/section-524b) both require a CVD process: a public point of contact, a documented intake and triage workflow, a commitment to communicate with reporters, and a process for issuing advisories. The HSCC "Medical Device and Health IT Joint Security Plan" provides MedTech-specific CVD templates. ENISA's CVD policy and CISA's Binding Operational Directive 20-01 set parallel expectations for federal use cases. 

## What this means in practice

A working CVD program needs a published security.txt file or vendor security page, a monitored intake address (security@), an SLA-driven triage process, integration with  [CAPA](/terms/capa), and a coordinated-release plan with affected customers and ISACs. Mature MedTech teams also offer  [Safe](/terms/safe-note) Harbor language so good-faith researchers aren't deterred by legal risk. 

Common pitfalls

-   • No published intake channel - researchers default to public disclosure when they can't reach you. 
-   • Treating CVD intake as a security-only problem; legal, comms, and clinical-affairs all need playbooks. 
-   • Publishing advisories without a working VEX/SBOM bridge so operators know which devices need action. 

## Frequently asked questions

Do we need a bug bounty? 

Not required. A bounty can attract more reports but adds program overhead. Most MedTech CVD programs start without a bounty and add one later if researcher engagement justifies it. 

What's a security.txt file? 

When should we publish the advisory? 

## Cross-references

### Used by

Things that build on this term.

-   [
    
    Section 524B of the FD&C Act(524B) 
    
    
    
    ](/terms/section-524b)

## Related terms

Grouped by theme 

### Editor's picks

· Hand-selected related concepts 

[

Cybersecurity

HSCC Joint Security Plan(HSCC JSP) 

An industry-developed reference framework from the Healthcare Sector Coordinating Council for end-to-end MedTech cybersecurity.





](/terms/hscc-jsp)[

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

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)[

Cybersecurity

Brainjacking

Unauthorized remote control of an implanted neurostimulator (e.g., DBS) to alter stimulation parameters and harm a patient.





](/terms/brainjacking)

Cited by

Where this term appears across MedTech Terms.

Ecosystems (1)

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

## Primary references

4 sources 

Link health:  4 verified · last checked 2026-06-20 

ISO/IEC· 2 FDA· 1 IETF· 1 

1.  [1 
    
    ISO/IEC 29147:2018 - Vulnerability disclosure
    
    Verified 
    
    ISO/IEC · iso.org 
    
    
    
    ](https://www.iso.org/standard/72311.html)
2.  [2 
    
    ISO/IEC 30111:2019 - Vulnerability handling processes
    
    Verified 
    
    ISO/IEC · iso.org 
    
    
    
    ](https://www.iso.org/standard/69725.html)
3.  [3 
    
    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)
4.  [4 
    
    RFC 9116 - security.txt
    
    Verified 
    
    IETF · rfc-editor.org 
    
    
    
    ](https://www.rfc-editor.org/rfc/rfc9116.html)

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

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On this term

Category

Cybersecurity

Acronym

CVD

Sources

4

Updated

5/5/2026

[Compare with another term](/compare?a=cvd)

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Card Lesson Quiz

A documented process for receiving, triaging, and responsibly disclosing security vulnerabilities reported by external researchers.

-   · Mature MedTech teams also offer Safe Harbor language so good-faith researchers aren't deterred by legal risk. 
-   · ISO/IEC 29147:2018 defines the disclosure process and ISO/IEC 30111:2019 defines the internal handling process. 
-   · FDA, CISA, and ENISA all expect MedTech manufacturers to operate a CVD program. 

Remember this

Watch out: No published intake channel - researchers default to public disclosure when they can't reach you.

Related terms

-   [Section 524B of the FD&C Act(524B) ](/terms/section-524b)
-   [HSCC Joint Security Plan(HSCC JSP) ](/terms/hscc-jsp)
-   [Premarket Cybersecurity Submission ](/terms/premarket-cybersecurity)

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