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Commercialization [Hospital Buyer & Reimbursement](/ecosystems/hospital-buyer)VAC 

# Value Analysis Committee

Hospital cross-functional committee that reviews and approves new product purchases.

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

## Definition

A VAC (sometimes called a New Product Committee or Technology Assessment Committee) brings together clinicians, supply chain, finance, and quality to evaluate the clinical evidence, cost, integration burden, and supply considerations of proposed new products. 

What the regulation says

While Value Analysis Committees (VACs) are primarily a commercialization and procurement function, medical device manufacturers must consider the implications of VAC reviews within their regulatory and quality management systems. For instance,  [post-market surveillance](/terms/post-market-surveillance) data and real-world performance collected as part of regulatory requirements, such as those under FDA 21 CFR Part 822 for postmarket surveillance or EU  [MDR](/terms/mdr-reporting) Article 83 for post-market surveillance systems, can significantly influence VAC assessments of a device's ongoing safety and effectiveness. Device changes requiring new regulatory submissions (e.g., FDA 510(k) modifications) or impacting clinical performance or safety will inherently affect a VAC's re-evaluation. 

## What this means in practice

VAC approval is often the gating  [step](/terms/step) for hospital adoption. Effective VAC submissions combine clinical evidence, total cost of care impact, and operational readiness materials. 

## Examples

-   A manufacturer provides the VAC with a summary of their FDA 510(k) clearance letter and a copy of their Declaration of Conformity to the EU MDR for their new surgical robot.
-   For a new infusion pump, the company presents its cybersecurity vulnerability management plan and evidence of compliance with AAMI TIR99:2023, "Identity and access management in healthcare," to the hospital's IT and VAC members.
-   When evaluating a new diagnostic test, the VAC reviews the independent clinical study data that supported the device's regulatory approval and post-market surveillance reports showing sustained performance.

Common pitfalls

-   • Failing to provide clear, concise evidence of regulatory clearances or approvals can delay VAC review. 
-   • Overlooking the importance of cybersecurity documentation, especially for connected devices, can be a major VAC hurdle. 
-   • Submitting outdated or non-relevant clinical evidence will undermine a product's credibility with the VAC. 
-   • Not understanding the specific evidence requirements of each hospital system's VAC can lead to repeated submissions and delays. 
-   • Ignoring the total cost of ownership, including training, maintenance, and disposables, can lead to VAC rejection despite clinical benefits. 

## Frequently asked questions

How does cybersecurity factor into a VAC's decision? 

For connected medical devices, VACs increasingly require robust cybersecurity documentation, including adherence to standards like NIST SP 800-53 or specific FDA guidance on cybersecurity in medical devices, to assess potential risks to patient data and hospital networks. A device's cybersecurity posture is a critical component of its overall value and risk profile. 

Should regulatory submissions be shared with a VAC? 

What kind of quality data is relevant to a VAC? 

## Related terms

Grouped by theme 

### Editor's picks

· Hand-selected related concepts 

[

Commercialization

Group Purchasing Organization(GPO) 

Entity that aggregates hospital purchasing to negotiate prices with suppliers.





](/terms/gpo)[

Commercialization

Integrated Delivery Network(IDN) 

Network of healthcare facilities under common ownership or affiliation.





](/terms/idn)

### More in Commercialization

· Same category 

[

Commercialization

AdvaMed Code of Ethics

Industry code governing interactions between U.S. medical-device companies and healthcare professionals.





](/terms/advamed-code)[

Commercialization

Advisory Board

Convening of external experts to advise on strategy or product.





](/terms/advisory-board)[

Commercialization

Anti-Kickback Statute(AKS) 

U.S. criminal statute prohibiting remuneration to induce federal healthcare business.





](/terms/anti-kickback)[

Commercialization

Bottom-Up Market Sizing

Building market size from procedure volumes × price × penetration.





](/terms/bottom-up-sizing)

Cited by

Where this term appears across MedTech Terms.

Ecosystems (1)

-   [Hospital Buyer & Reimbursement](/ecosystems/hospital-buyer)

## Mentioned in recent activity

1 entry 

Recalls (1)

[Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Description: The Clinical Innovations Kiwi is a disposable vacuum assisted fetal delivery system. It is a sterile, single-patient-use device designed to provide assistance in childbirth under the following conditions: 1) Term pregnancy, 2) Ruptured amniotic membranes, 3) Engaged head, 4) Complete cervical dilation, and 5) Adequately trained or supervised operator. ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-1945-2026)

Class II · 2026-03-09 

## Latest in MedTech

[View all](/latest?term=vac)

Recent regulatory actions, publications, and trials matched to this term. Updated daily.

-   Recall 2026-03-09 
    
    [Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Description: The Clinical Innovations Kiwi is a disposable vacuum assisted fetal delivery system. It is a sterile, single-patient-use device designed to provide assistance in childbirth under the following conditions: 1) Term pregnancy, 2) Ruptured amniotic membranes, 3) Engaged head, 4) Complete cervical dilation, and 5) Adequately trained or supervised operator. ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-1945-2026)
    
    Class II · Clinical Innovations, LLC
    

## Primary references

2 sources 

Link health:  2 verified · last checked 2026-06-20 

AHRMM· 1 AdvaMed· 1 

1.  [1 
    
    AHRMM Value Analysis
    
    Verified 
    
    AHRMM · ahrmm.org 
    
    
    
    ](https://www.ahrmm.org/)
2.  [2 
    
    AdvaMed Code of Ethics
    
    Verified 
    
    AdvaMed · advamed.org 
    
    
    
    ](https://www.advamed.org/our-work/code-of-ethics/)

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

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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

Commercialization

Acronym

VAC

Sources

2

Updated

5/5/2026

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Card Lesson Quiz

Hospital cross-functional committee that reviews and approves new product purchases.

-   · VAC approval is often the gating step for hospital adoption. 
-   · Effective VAC submissions combine clinical evidence, total cost of care impact, and operational readiness materials. 

Remember this

Watch out: Failing to provide clear, concise evidence of regulatory clearances or approvals can delay VAC review.

Related terms

-   [Group Purchasing Organization(GPO) ](/terms/gpo)
-   [Integrated Delivery Network(IDN) ](/terms/idn)

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