FDA Powered Exoskeleton Special Controls
Exoskeleton manufacturers get and running with the Aligned Elements Exoskeleton Extension Package containing:
- 9 Potential Hazards (including suggested mitigations measures) outlined as exoskeleton associated risk factors by the FDA
- 38 exoskeleton Special Control Requirements deduced from 21 CFR Part 890 Docket No. FDA-2014-N-1903
This gives manufacturers a predefined starting point when setting up their Design History File with the intention of accelerating the documentation effort.
Unzip the downloaded file and import the extracted files into Aligned Elements. When importing this extension, make sure that the "Recreate chapters" option is selected in the import dialog.