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FDA Hopes To Balance Upfront Time Investment With Easier Reviews In New PMA Program

CDRH Director Jeffrey Shuren hopes that the early, concentrated collaboration that his staff will engage in with manufacturers for select “Expedited Access PMA” devices will make the reviews themselves substantially quicker and easier, he said in an interview.

FDA device center officials hope they can balance the substantial resources that they would need to invest into products accepted into CDRH’s newly proposed “Expedited Access PMA” pathway with a more straightforward, less- intensive review process, but the jury is still out, Center Director Jeffrey Shuren says.

“It may turn out that we spend more resources upfront with an innovator, but actually save some resources later on...

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