Postmarket Safety

ARTICLES

ANSM Sees Uptick in Adverse Event Reports for Bayer IUD

France’s National Agency for the Safety of Medicines reported a major uptick in adverse advents associated with Bayer’s Mirena intrauterine device. Read More

Jury Returns Verdict in Defective J&J Hip Implants Case

A federal court jury in Texas returned a $247 million verdict on behalf of six individuals who said they suffered serious medical complications from metal-on-metal Pinnacle Acetabular Cup System hip implants made by the Johnson & Johnson subsidiary DePuy Orthopaedics. Read More

House Sets Deadline for HHS to Develop Bill of Materials Action Plan

The House Energy and Commerce Committee is giving the Department of Health and Human Services until no later than Dec. 15 to come up with an action plan for creating “bills of materials” to enhance cybersecurity for healthcare technologies. Read More

FDA Adds Contraindication to Labeling of Ultrasonic Surgical Aspirators

The FDA has recommended the addition of a contraindication for the use of certain ultrasonic surgical aspirator devices for removing uterine fibroids. Read More

FDA to Release a New Version of Submission Software

FDA software used by medical device manufacturers to submit reports of adverse events, corrections and removals is being updated without any downtime for the first time. Read More

FDA Cites Devicemaker Over MDR, GMP Violations

An inspection in March by the FDA of ELITech Group’s facility in Spankeren, The Netherlands prompted a warning letter after the device manufacturer failed to follow through with the promises made in response to a Form 483 report. Read More

FDA Warns German Device Firm Over Adulteration, Misbranding

German-based devicemaker DRG Instruments drew a warning letter from the FDA and the agency said it would refuse entry of the company’s medical devices to the U.S. market because they were adulterated and misbranded. Read More

Lawmakers Question FDA on Bayer’s Essure Device

Three members of Congress sent a letter to FDA Commissioner Scott Gottlieb to request a meeting to address the agency’s inaction on the numerous reports of adverse events… Read More

FDA Warns Pelvic Therapies to Cease Unapproved Activities

The FDA warned Pelvic Therapies in Carlsbad, California to “immediately cease activities” that resulted in the medical devices manufactured at its facility being adulterated and misbranded. Read More

Magellan Distributed Unapproved Testing Systems, FDA Says

The FDA sent an Oct. 23 warning letter to Magellan Diagnostics as part of an ongoing investigation based on data showing its blood lead testing systems provided false results. Read More