FDA review risk classification of absorbable haemostatic devices:
This article was originally published in Clinica
The US FDA is proposing to down-classify absorbable haemostatic devices intended to staunch blood flow during surgery. These products are currently class III devices, requiring clinical trials, but have been on the market for several years and are now considered safe enough to move to class II, the agency announced on October 31. This will allow companies to file a 510(k) without studying their device in humans if they follow the premarket advice of a new proposed guidance document released on the same date. Comments are due by January 27.
You may also be interested in...
The Environmental Working Group and Scientific Analytical Institute say inadequate testing of talc-containing personal-care products is to blame for findings of asbestos in cosmetics, including three of 21 powder-based cosmetics SAI analyzed at EWG’s request. They continue to push for updated testing standards that include electron microscopy as a core component.
Can Atlas Biomed unlock Japan's self-care market with its direct-to-consumer DNA and microbiome tests? HBW Insight catches up with the company's co-founder and CEO to discuss this and also how Atlas has been driving its European expansion plans despite coronavirus.
France's ANSES warns women using oral contraceptives not to use a supplement marketed by UK firm Hairburst after linking the product's consumption to two cases of severe acute hepatitis.