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First Condom Authorized For US Market With Anal Sex Indication

 
• By Malcolm Spicer

The de novo authorization included the creation of a 510(k) pathway for similar devices in the future, allowing other condoms with the same function to reach market more easily.

Condom unrolled to cover a banana.
• Source: Ekaterina Minaeva / Alamy Stock Photo

A condom that is designed to help reduce transmission of sexually transmitted infections during anal intercourse has been cleared for the first time in the US. The authorization comes through a regulatory pathway likely to spur more submissions for condoms carrying the indication

The US Food and Drug Administration has authorized Global Protection Corp.’s One brand natural rubber latex condom to use the...

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Study: FDA’s Breakthrough Path Speeds Access, But Raises Safety Questions

 
• By Elizabeth Orr

Research recently published in JAMA Internal Medicine found that the FDA met its review timeline goals for the majority of breakthrough devices – but also revealed some apparent shortcomings in safety data supporting the submissions.

More from Policy & Regulation

FDA Panel Supports Dermal Fillers For Décolletage Use

 
• By Elizabeth Orr

An FDA panel has endorsed the use of dermal fillers for décolletage, but warned of patient safety concerns. The filler can cause complications with future imaging and pregnancy or breastfeeding, panelists said. Regulatory measures and patient studies are recommended for better outcomes.

NAD Alerts Agendia Over Endorsing Physician’s Ties To Firm

 
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The National Advertising Division (NAD) alerted Agendia to improve disclosure regarding a physician endorsing its MammaPrint test. The physician's ties to Agendia were inadequately revealed in LinkedIn posts.

FDA Ends Effort To Regulate LDTs By Rescinding Final Rule

 
• By Brian Bossetta

Just a year and four months after publishing a final rule that would have allowed it to regulate laboratory developed tests as medical devices, the US FDA has rescinded the controversial measure, finally putting an end to the saga.