The draft guidance aims to shed light on appropriate responses to nonconforming product or regulatory compliance issues related to diagnostic and therapeutic medical devices, but does not apply to premarket review decisions. Once finalized, it is intended to provide a shared benefit-risk framework and to set forth overarching principles for FDA staff and stakeholders.

In this draft guidance document titled “Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions,” the FDA highlights the benefit and risk factors it may take into consideration when prioritizing resources for compliance and enforcement efforts. The agency stresses the importance of carefully weighing risk-benefit profiles when determining the appropriate regulatory action, as failure to do so “could result in regulatory actions with unintended adverse effects (e.g., shortage of medically necessary devices).”

When determining the appropriate regulatory action, the following factors may be considered on a case-by-case basis when evaluating a device’sbenefits:

  • Type of benefit(s) – including the medical device’s impact on patient health and clinical management.
  • Magnitude of benefit(s) – the degree to which patients experience the treatment benefit or the effectiveness of the medical device.
  • Likelihood that the medical device will effectively treat or diagnose the patient’s disease or condition.
  • Duration of effects – how long the benefit can be expected to last for the patient.
  • Patient preference on benefit – the value that patients place on use of the medical device.
  • Benefit factors for health care professionals or caregivers – includes the benefit that health care professionals or caregivers experience by improving the way they care for patients, whether this directly improves patient outcomes or improves clinical practice.
  • Medical necessity – whether the medical device provides benefits or addresses needs unmet by other medical devices or therapies.

The following factors are taken into account on a case-by-case basis when assessing a device’s risks:

  • Risk severity – This is categorized into three levels and includes a duration component. The three levels are:
    • Medical device-related deaths and serious injuries.
    • Medical device-related nonserious adverse events.
    • Medical device-related events without reported harm.
    • Likelihood of risk – The FDA considers three risk factors related to:
      • Likelihood of medical device nonconformity.
      • Likelihood of a harmful event given exposure to a nonconforming device.
      • Number of patients exposed.
      • Nonconforming product risks.
      • Duration of exposure to population.
      • False-positive or false-negative result.
      • Patient tolerance risk.
      • Risk factors for health care professionals or caregivers.

Other factors that may be taken into account include uncertainty, mitigations, detectability, failure mode, scope of the device used, patient impact, preference for availability, nature of violations/nonconforming product and firm compliance history.

Additionally, the FDA says the draft guidance is meant to align the benefit-risk factors it applies in the above context with those it considers when evaluating marketing and IDE applications.