New Guidance Details FDA's Benefit-Risk Framework for Device Compliance, Enforcement Decisions

Posted 17 June 2016 | By Michael Mezher 

New Guidance Details  FDA's Benefit-Risk Framework for Device Compliance, Enforcement Decisions

The US Food and Drug Administration (FDA) earlier this week released a new draft guidance detailing its approach to considering the benefits and risks for compliance and enforcement actions that could impact medical device availability.

FDA says it must take care when making such decisions due to the potential for compliance and enforcement actions, such as product recall or withdrawal, to negatively impact patients.

"Failure to consider the short-term and long-term impact on non-compliance on the benefit-risk profile of the device and the benefit-risk tradeoffs of FDA's decision options on the health and quality of life of patients could result in regulatory actions with unintended adverse effects (e.g., shortage of medically necessary devices)," FDA writes.

Additionally, FDA says the draft guidance is meant to bring its benefit-risk framework for such decisions more in line with how it considers benefit and risk for marketing and investigational device exemption (IDE) application decisions.

"While the benefit-risk factors in this draft guidance are not identical to the other frameworks, this draft guidance builds upon FDA's premarket review benefit-risk policy in an effort to improve consistency in our patient centered approach and decision making process across the total product life cycle," FDA writes.

According to FDA, when it comes to making such compliance and enforcement decisions, the agency will consider any "relevant and reliable" information pertaining to the device in question, including "reliable patient preference information from a representative sample."

In particular, FDA says it considers the following factors when considering a device's benefit in light of compliance and enforcement decisions:

  • Type of benefit(s)
  • Magnitude of benefit(s)
  • Likelihood of patients experiencing one or more benefits
  • Duration of effects
  • Patient preference on benefit
  • Benefit factors for healthcare professionals or caregivers
  • Medical necessity

For risks, FDA says it considers the following factors:

  • Risk severity
    • Medical device-related deaths and serious injuries
    • Medical device-related non-serious adverse events
    • Medical device-related events without reported harm
    • Duration of harm to patient
  • Likelihood of risk
    • 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 healthcare professionals or caregivers

Additionally, FDA says it can take other factors into account as well, including:

  • Uncertainty
  • Mitigations
  • Detectability
  • Failure mode
  • Scope of the device used
  • Patient impact
  • Preference for availability
  • Nature of violations/Nonconforming product
  • Firm compliance history


Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles