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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

 
• By Shawn M. Schmitt

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.

Bayer AG, German multinational pharmaceutical and life sciences company, one of largest pharmaceutical companies in world, brand logo on its office building located in Lyon, France - February 23, 2020

The US Food and Drug Administration has given Bayer AG a green light to roll up potentially thousands of adverse event reports about its problematic – and now-defunct – Essure birth control device into monthly spreadsheets.

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