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    Physician Training and Proctoring

    Structured education and supervised cases for physicians adopting a new device.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    Training and proctoring programs prepare physicians to safely use a new device through didactic content, simulation, cadaver labs, and supervised first cases by experienced proctors. Often required by the device label or facility credentialing.
    What the regulation says
    Physician training programs are essential for ensuring the safe and effective use of MedTech devices, especially high-risk devices. The FDA expects manufacturers to provide adequate training as part of their post-market surveillance and risk management activities, often outlined in labeling, instructions for use (IFUs), and sometimes in post-market study requirements or Risk Management Plans per ISO 14971. In some cases, specific training requirements might be detailed in a 510(k) clearance letter or PMA approval order. The EU MDR, in Annex I, General Safety and Performance Requirements (GSPRs) points 14.1 and 23.4, emphasizes the need for devices to be designed and manufactured in a way that facilitates safe use by lay users or qualified healthcare professionals, which implicitly includes appropriate training provisions where necessary.

    What this means in practice

    Adoption velocity correlates with training capacity. Proctor agreements must comply with AdvaMed Code and AKS - fair-market-value compensation, documented services, no inducement.

    Examples

    • A manufacturer of a novel cardiac ablation catheter develops a training program including didactic modules, simulator training, and supervised cases, as required by their PMA approval conditions.
    • A new orthopedic implant
    • s instructions for use (IFU) specify that surgeons must complete a proctored surgery with an experienced peer before independent use.
    Common pitfalls
    • •Failing to document physician training and proctoring activities adequately can lead to non-compliance during audits and adverse event investigations.
    • •Offering inappropriate or excessive remuneration for proctoring services can violate anti-kickback statutes (e.g., U.S. Anti-Kickback Statute) and industry codes like the AdvaMed Code of Ethics.
    • •Not updating training materials when device modifications occur can result in physicians using outdated techniques with a modified device.
    • •Using proctors who lack sufficient qualifications or experience can compromise patient safety and the effectiveness of the training program.
    • •Neglecting to establish clear criteria for successful completion of proctoring can lead to inadequately trained physicians.

    Frequently asked questions

    The primary purpose is to ensure that physicians are competent and confident in safely and effectively using new or complex MedTech devices, thereby reducing risks to patients and optimizing device performance.
    Grouped by theme

    Primary references

    2 sources
    Link health: 2 verified· last checked 2026-06-20
    AdvaMed·1AHRMM·1
    1. 1
      AdvaMed training
      Verified
      AdvaMedadvamed.org
    2. 2
      AHRMM - Healthcare Supply Chain
      Verified
      AHRMMahrmm.org

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