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Republican Congress, Trump Policies May Seek To 'Undo' FDA Device Safety Guidances; LDT Plan First To Go

 
• By Sue Darcey

Emboldened by a Republican victory in the White House, GOP members of Congress are already putting the screws on federal agencies to back off on health and safety regulations and guidances for products, with some success – for example, FDA's Nov. 18 decision to shelve its proposed laboratory developed test guidance in final form seems to be a response to the new political reality in DC.

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Industry attorneys and health consultants are predicting a new policy climate in Washington for health care regulations following the Nov. 8 elections and the choice of Donald Trump as president; one of the first policies to be impacted by the new approach, is a pending laboratory-developed test oversight framework from FDA.

"Certainly a focus of the Trump campaign was reducing regulation on industry, so I do believe there will be a...

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• By Elizabeth Orr

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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

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• By Elizabeth Orr

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Permanent FDA Top Lawyer Expected After HHS Counsel Confirmation

 
• By Sue Sutter

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The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.