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Leap Ahead With EAP? FDA Proposes New Expedited PMA Pathway

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.

FDA’s newly proposed accelerated PMA program may have a long name, but the agency hopes it will significantly shorten the time to market for a select set of devices that target unmet needs for the most serious conditions.

The “Expedited Access Premarket Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions,” or EAP, was introduced today in a draft guidance,...

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