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US Approvals Analysis: Slow Month For PMAs, Better For 510(k)s

 
• By David Filmore

PMA, supplement and de novo approvals from US FDA came in relatively low in November, while the agency's 510(k) clearance volume was ahead of the 2016 average. Highlighted clearances for the month include an expanded indication for Medtronic's Solitaire stent retriever system for stroke and Brightwater Medical's ConvertX nephroureteral stent system for ureteral obstructions.

FDA approved background, 3D rendering, blue street sign

[Editors' note: For sortable and searchable tables of all 2016 US and non-US approvals and clearances, check out ourApprovals Tracker.]

November was a relatively quiet month for FDA device approvals, but it was a healthy period for 510(k) clearances.

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• By Elizabeth Orr

With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.

With LDT Rule DOA, Could FDA Shift Focus To RUOs?

 
• By Brian Bossetta

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• By Derrick Gingery and Sue Sutter

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• By Brian Bossetta

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More from North America

MDUFA VI Launches With Public Meeting, Call For Comments

 
• By Elizabeth Orr

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Permanent FDA Top Lawyer Expected After HHS Counsel Confirmation

 
• By Sue Sutter

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FDA Drops Package Labeling Guidance For Hernia Mesh Manufacturers

 
• By Brian Bossetta

The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.