The benefit-risk factors may be considered when device manufacturers evaluate appropriate responses to nonconforming product or regulatory compliance issues, such as determining whether to limit the availability of a medical device (e.g., a voluntary recall or market withdrawal). FDA may consider the benefit-risk factors during, for example, evaluation of device shortage situations, selection of the appropriate regulatory engagement mechanism following an inspection during which regulatory non-compliance was observed, evaluation of recalls, and consideration of petitions for variance from those sections of the Quality System (QS) regulation (21 CFR part 820) for which there were inspectional observations during a Premarket Approval (PMA) pre-approval inspection.