Catalog of Regulatory Science Tools to Help Assess New Medical Devices
The DAMSEL tool was developed in partnership with ECRI (www.ECRI.org).
Intended Purpose
The DAMSEL tool is intended as an aid to innovators when making selection of materials in the design phase of medical device development.
Testing
QC testing of the DAMSEL tool was undertaken by ECRI (www.ECRI.org).
Limitations
The DAMSEL tool is not intended to make specific recommendations for designing novel medical devices, but instead provides collated information to assist innovators in their decision-making process. FDA gives no guarantee that the use of DAMSEL provides any regulatory advantage or short cut to marketing approval of a medical device.
Supporting Documentation
- The app can be found in publicly accessible form here.
- Specific detailed reports on the materials investigated can be found on the FDA website here.
Contact
For more information: