Guidance for Off-The-Shelf Software Use in Medical Devices
Guidance for Off-The-Shelf Software Use in Medical Devices
Guidance for Off-The-Shelf Software Use in Medical Devices
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PrefacePublic CommentComments and suggestions may be submitted at any time <strong>for</strong> Agency consideration toDonna-Bea Tillman, <strong>Off</strong>ice of Device Evaluation at dbt@cdrh.fda.gov or at 301-443-8517. Comments may not be acted upon by the Agency until the document is next revisedor updated. For questions regard<strong>in</strong>g the use or <strong>in</strong>terpretation of this guidance contactDonna-Bea Tillman at dbt@cdrh.fda.gov or at 301-443-8517. Questions regard<strong>in</strong>g theuse or <strong>in</strong>terpretation of this guidance <strong>for</strong> a particular device should be directed to theappropriate ODE review division.Additional CopiesWorld Wide Web/CDRH home page: http://www.fda.gov/cdrh/ode/1252.pdf, or CDRHFacts on Demand at 1-800-899-0381 or 301-827-0111, specify number 1252 whenprompted <strong>for</strong> the document shelf number.OTS <strong>Software</strong> <strong>Guidance</strong>, F<strong>in</strong>al page ii
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