Factors to be considered for benefits vs Risk analysis by analysis.

Uncertainty:is an important factor, since at any point in the total product life cycle, there is never
100% certainty regarding the safety, effectiveness, or quality of a device. However, the degree of
certainty of the benefits and risks of a device is a factor FDA considers when making benefit-risk
assessments.

Mitigation:are actions taken by the manufacturer, by FDA, or by other stakeholders to recover
benefit or to limit harm. Mitigations could address, among other considerations, as applicable:
clinical practice; use errors; unmet medical needs; the use environment; user population; user
skill level; clinical understanding in assessing risk; current expectations in clinical use; any
changes in medical practice etc.

Detectability refers to whether nonconformity could be identified, either by the manufacturer
or by the user. A nonconformity which can be identified prior to use of the device may harm
fewer patients than a nonconformity which is not identified prior to use.

Failure mode is the specific method or type of failure. The failure mode may be used to identify
the cause of the nonconformance, including whether the nonconformance is related to
manufacturing, design, use conditions, or environment.

Scope of the device issue should be evaluated to assess whether the risks identified are potentially
inherent to similar devices of this type

Patient impact is the impact on the health and quality of life of patients if a particular compliance
or enforcement action is, or is not, taken or if the device relevant to the nonconformity or
regulatory non-compliance is not available.

Firm compliance history may include the manufacturer’s regulatory history and initiative in
identifying and correcting issues, the repetitiveness of such issues, and the manufacturer’s
communication with FDA.