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Enforcement & Litigation

Set Alert for Enforcement and Legislation

FDA Sends Warning Letters To OTC Dermal 'Pen' Firms, While Professional Microneedling Device Gets Award

The US FDA sent warning letters to Flawless Beauty & Skin and Med Pen Concepts for selling allegedly noncompliant medical devices. Meanwhile, Crown Aesthetics's SkinPen Precision was named “Best in Industry-Nonsurgical Innovation” by The Aesthetic Guide.

Regulation OTC Devices FDA

EU Plenary Debates How To Protect Orphan Devices From MDR Crisis

Steps are being taken in the EU to address shortages of critical medical devices as a result of regulatory pressures, including those for use in children and for rare conditions, the European Commission’s Stella Kyriakides stated during a recent debate.

Europe EU

It’s A Class I Recall For Baxter’s WatchCare Device

Radiofrequencies from the incontinence-sensing devices may interfere with other medical equipment in a hospital setting. 

Recalls Regulation

It’s A Class I Recall For Baxter’s WatchCare Device

Radiofrequencies from the incontinence-sensing devices may interfere with other medical equipment in a hospital setting. 

Recalls Regulation

Ex-Theranos CEO Elizabeth Holmes Sentenced To 11-Year Prison Term

The former diagnostics company executive was convicted in January on four counts of fraud.

Legal Issues Policy

Sterigenics Wins Second Lawsuit In Ongoing Ethylene Oxide Court Battles

In the second trial over Sterigenics’ ethylene oxide plant emissions, the Cook County, IL jury found Stergiencs not liable for cancer in a woman who lived near the plant.

Safety Legal Issues

AdvaMed Urges Biden Administration To Use CHIPS To Prioritize Patient Care

Now that the CHIPS and Science Act is law, AdvaMed wants the Biden administration to use it to ensure device makers get the semiconductor chips they need for their products while preventing the US from facing another shortage of the essential components, as experienced during the pandemic.

Medical Device Policy

Johnson & Johnson Asks Supremes To Take Up Pelvic Mesh Litigation

The firm says that California laws that lead to a $300m jury verdict against subsidiary Ethicon for deceptive marketing of pelvic mesh violate due process standards.

Legal Issues Policy

Exec Chat: Cybersecurity Regulations Aren’t Burdensome But ‘Best Practice’

Impero senior vice president of products Sam Heiney spoke to Medtech Insight about reframing the way medtech and healthcare organizations think about cybersecurity regulations.

Cybersecurity Policy
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