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New FDA Guidance Offers Additional Info On eStar Submissions

 
• By Brian Bossetta

The US Food and Drug Administration says its guidance for manufacturers seeking premarket clearance is part of the agency’s overall commitment to improve e-submission consistency and enhance the review process.

FDA LAPTOP.
• Source: Alamy

The US Food and Drug Administration issued a draft guidance document on 29 September to update device makers on the agency’s eSTAR (electronic Submission Template And Resource) program for electronic 510(k) applications to the agency’s devices and biologics centers.

In 2017, Congress directed the FDA to create and publish standards for electronic submissions. The agency’s first move in the...

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FDA Panel Supports Dermal Fillers For Décolletage Use

 
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FDA Changes Fail To Diminish US Appeal To European Medtech Industry

 
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Environmental Group Questions FDA’s Stance On PFAS In Medical Devices

 
• By Brian Bossetta

The US FDA says PFAS used in medical devices are safe and that there’s no reason to restrict them in device production. An environmental group finds the agency’s assertion questionable.

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a final rule that would have allowed it to regulate laboratory developed tests as medical devices, the US FDA has rescinded the controversial measure, finally putting an end to the saga.