Manufacturer omission of MDR user facility data is common deficiency, FDA says.
This article was originally published in The Gray Sheet
MANUFACTURER MDR REPORTS OMITTING USER FACILITY DATA is a common deficiency in medical device adverse event reports submitted to FDA, according to agency staffers. Many device companies are neglecting to complete Section F of the 3500A MDR form when it is left blank by user facilities or distributors, FDA says.
You may also be interested in...
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.
A lower first dose boosted the vaccine’s efficacy result, but AstraZeneca has conceded that this has to be proven in a separate trial. In the meantime, the UK government has asked the regulator to assess the vaccine under a special health emergency provision.