FDA Hopes To Balance Upfront Time Investment With Easier Reviews In New PMA Program
This article was originally published in The Gray Sheet
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.
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A system using nerve stimulation to treat diaphragm atrophy in mechanical ventilation patients is the latest product to be granted EAP designation. FDA officials recently confirmed that 17 devices have been accepted to the expedited development pathway about a year after the program launched.
Companies want FDA to expand the bounds of its accelerated device development program, while others urge FDA to be cautious.
The newly proposed “expedited access” PMA program combines early and outsized interactions between reviewers and manufacturers with the promise of lightened premarket requirements for selected products – if the potential payoff to patients is large enough and postmarket controls are sufficient.