Essure: FDA Grants Bayer Variance From MDR Reporting For Certain Adverse Events Found On Social Media
The agency’s move lets Bayer file only one 3500A reporting form a month for potentially thousands of events uncovered during litigation
The US agency in a 24 April letter approved Bayer’s request for a deviation from traditional Medical Device Reporting requirements. The variance applies to MDR-reportable events related to the problem-prone Essure device that Bayer is or becomes aware of from social media between November 2016 and November 2020, as part of ongoing litigation around the product.
