Guidance: FDA Weighs Risk-Benefit Factors When Making Device Enforcement Decisions

If the FDA conducts a benefit-risk assessment and finds the device has a high benefit to patients and the compliance issue causes little risk, it may decide to work with a company informally, rather than taking an official enforcement action.

The FDA may also use the benefit-risk assessment to decide if a company’s proposed correction strategy is adequate, new draft guidance says.

Manufacturers can use the same benefit-risk factors when choosing their responses to nonconforming product or compliance issues, the guidance says. This can include deciding whether to conduct a recall or take other actions that might affect device availability.

When the FDA assesses device benefits, it considers the:

  • Type of benefit, such as impact on survival, improved patient function or symptom relief;
  • Likelihood of patients experiencing benefits;
  • Duration of effects;
  • Patient preference, which is the value that patients place on the device;
  • Benefits for healthcare professionals or caregivers; and
  • Medical necessity.

“Benefit considerations should include an assessment of whether another medical device or therapy could be used in substitution, and the availability of that other medical device or therapy,” the guidance says. The assessments may help the FDA decide whether a product correction would be better than a removal, and how to manage access to a nonconforming device during a shortage.

Benefit factors may need to be reassessed at later points in the product life cycle, after a device is widely used. Sources of benefit information can include literature, prior premarket submissions, clinical studies, registries, patient input, knowledgeable clinicians and risk management documentation from the manufacturer.

The guidance also discusses risk considerations, which include the:

  • Severity, categorized into three levels: deaths or serious injuries, non-serious events or events without reported harm;
  • Likelihood of risk, which also considers the total number of patients that would be exposed to the risk;
  • Nonconforming product risks, such as how many nonconforming devices are on the market;
  • Duration of exposure;
  • False-positive or false-negative results; and
  • Risk factors for healthcare professionals or caregivers.

The scope of the device issue should also be evaluated to see whether the risks could be present in similar devices, the guidance says.

The risk factors may need to be reassessed later in the product life cycle, after the device is widely used. Manufacturers should note any changes in risk in their risk-management documentation, the guidance says.

FDA assessments may consider additional factors including uncertainty, mitigations, detectability, failure mode, patient impact, nature of violations/nonconforming product and company compliance history.

In addition to compliance decisions, the FDA may assess benefit-risk factors during evaluation of device shortages, recalls and inspectional observations during PMA inspections.

Comments on the guidance are due Sept. 14. The draft guidance is available at — April Hollis


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