New Material Safety Reports Highlight Lack Of Data To Fully Evaluate Adverse Reactions
The US FDA and ECRI released four reports about the safety of certain materials used in medical devices. While the risks seem to be comparatively low, they note the quality of literature is lacking to make broad evaluations.
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The US FDA gives recommendations on the labeling of breast implants in a 29 September final guidance doc. The agency also revised a separate breast implant guidance last updated in 2006 to include, among other things, information found in the new labeling guidance.
Digital Health Roundup, August/September 2021: Record Digital Health Funding Q1-3 Of $21.3Bn, AAOS Highlights, Regulatory Updates
In this roundup of developments in digital health, we highlight the key news and announcements from August and September.
The US agency published a paper that’s based on recommendations from experts and other stakeholders on how to best let patients know their device may be vulnerable to a cybersecurity attack.