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| 1 | +# Audit checklist for the U.S. Food and Drug Administration (FDA)'s Guidance |
| 2 | +# document "Content of Premarket Submissions for Software Device Software |
| 3 | +# Functions" for devices requireing the "Basic" Documentation Level |
| 4 | +# Based on the draft version, published on 2021-11-04. |
| 5 | +# |
| 6 | +# This checklist is not a substitute for reading, understanding, and |
| 7 | +# implementing the associated guidance document, which can be found online for |
| 8 | +# free on https://www.fda.gov. The descriptive phrase following each keyword |
| 9 | +# reference is intended only as a helpful mnemonic for locating |
| 10 | +# and recalling the referenced section of the standard. |
| 11 | +# |
| 12 | +FDA-SW:dle A statement indicating the appropriate Documentation Level and rationale for that level |
| 13 | + |
| 14 | +FDA-SW:sd A summary overview of the features and software operating environment |
| 15 | +FDA-SW:sd-other Other software device functions |
| 16 | + |
| 17 | +FDA-SW:ssad Detailed diagrams of modules, layers, and interfaces that comprise the device |
| 18 | + |
| 19 | +FDA-SW:rmf-plan An ISO-14971-compliant plan that defines how the risk acceptability criteria |
| 20 | +FDA-SW:rmf-assessment A risk assessment table demonstrating that risks have been appropriately mitigated |
| 21 | +FDA-SW:rmf-report A risk management report that demonstrates how the plan was implemented |
| 22 | + |
| 23 | +FDA-SW:srs Software requirements specification |
| 24 | +FDA-SW:srs-tracking A description of the software requirement identification and tracking methodology |
| 25 | + |
| 26 | +FDA-SW:sdmp The software development and maintenance practices document |
| 27 | + |
| 28 | +FDA-SW:sdmp-dev-processes Processes and procedures used in software development |
| 29 | +FDA-SW:sdmp-vandv Processes and procedures used in verification and validation. |
| 30 | +FDA-SW:sdmp-cmt Standards (e.g., coding), methods and tools used in software development |
| 31 | +FDA-SW:sdmp-outputs Main deliverables of the typical software development and v-and-v activities |
| 32 | +FDA-SW:sdmp-traceability Processes, procedures, and tools used to handle traceability |
| 33 | +FDA-SW:sdmp-config Processes and procedures used in software configuration and change management |
| 34 | +FDA-SW:sdmp-maintenance Processes and procedures used in software maintenance |
| 35 | + |
| 36 | +FDA-SW:vandv Verification and validation documentation |
| 37 | +FDA-SW:vandv-summary Summary of the unit, integration, and system-level testing |
| 38 | +FDA-SW:vandv-changes Description and justification of changes made in respond to failed tests |
| 39 | +FDA-SW:vandv-regression-analysis Analysis of unintended effects of fixes |
| 40 | +FDA-SW:vandv-system-protocol System level testing protocol |
| 41 | +FDA-SW:vandv-system-report System level testing report |
| 42 | + |
| 43 | +FDA-SW:rlh Revision history log, including release version number and date |
| 44 | +FDA-SW:ua List of remaining software anomalies |
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