MedTech Terms
    The authoritative reference
    All terms
    CommercializationHospital Buyer & ReimbursementVAC

    Value Analysis Committee

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

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast 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 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 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 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

    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.
    Grouped by theme

    Mentioned in recent activity

    1 entry

    Latest in MedTech

    View all

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

    Primary references

    2 sources
    Link health: 2 verified· last checked 2026-06-20
    AHRMM·1AdvaMed·1
    1. 1
      AHRMM Value Analysis
      Verified
      AHRMMahrmm.org
    2. 2
      AdvaMed Code of Ethics
      Verified
      AdvaMedadvamed.org

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