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# 4 FDA/ECRI Material Safety Summaries Out
- URL: https://www.fdaweb.com/4-fda-ecri-material-safety-summaries-out/
- Published: 2021-09-22T12:00:00.000Z
- Updated: 2026-09-14T17:15:38.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150199

FDA, which partnered with ECRI, an independent nonprofit organization, to perform a comprehensive literature search and systematic review to identify the current state of knowledge about medical device material performance after implantation, has published the first four safety summaries. The [documents](https://www.fda.gov/medical-devices/science-and-research-medical-devices/medical-device-material-safety-summaries-ecri-reports?ref=fdaweb.com) cover magnesium, polypropylene, polyurethane, and siloxanes.

The review for each material focused on five key questions about local and systemic response to materials commonly used in medical devices: 

- the typical or expected local host response to the material;
- whether the material elicits a persistent or exaggerated response that may lead to systemic signs or symptoms beyond known toxicity problems;
- patient-related factors that may predict, increase, or decrease the likelihood and/or severity of an exaggerated, sustained immunological/systemic response;
- material-related factors that may predict, increase, or decrease the likelihood and/or severity of an exaggerated, sustained immunological/systemic response; and
- critical information gaps that exist and research that is needed to better understand the issue.