ABSTRACT

Medical device use environments have expanded beyond doctors’ of ces and hospitals to outpatient, community, and home care. The intended users have broadened from trained medical professionals (e.g., physician, nurse, or other health care provider) to include lay patients and caregivers. A variety of users and use environments require different ways

13.5.4.6 Label Must Produce Compliance ...............................................567 13.5.4.7 Labeling May In uence Users Indirectly ...................................567