FDA of­fers draft guid­ance for de­vice ‘pre-sub’ pro­gram

Modern Healthcare - - LATE NEWS -

The Food and Drug Ad­min­is­tra­tion is­sued draft guid­ance aimed at help­ing med­i­cal de­vice com­pa­nies ad­dress reg­u­la­tory re­quire­ments be­fore they sub­mit an ap­pli­ca­tion. The agency said the draft guid­ance builds on its ex­ist­ing pre-in­ves­ti­ga­tional de­vice ex­emp­tion pro­gram and will pro­vide re­searchers and man­u­fac­tur­ers with feed­back prior to sub­mis­sion of a prod­uct or re­search ap­pli­ca­tion. “No mat­ter the reg­u­la­tory path­way, FDA’s early feed­back on stud­ies can fa­cil­i­tate the de­vel­op­ment of a qual­ity pre­mar­ket sub­mis­sion and help in­dus­try avoid reg­u­la­tory hur­dles dur­ing the re­view process,” Christy Fore­man, di­rec­tor of the de­vice eval­u­a­tion of­fice in FDA’s Cen­ter for De­vices and Ra­di­o­log­i­cal Health, said in a news re­lease. The new pro­gram will be called the pre-sub­mis­sion, or “pre-sub,” pro­gram. It will op­er­ate within the in­ves­ti­ga­tional de­vice ex­emp­tion, pre­mar­ket ap­proval, hu­man­i­tar­ian de­vice ex­emp­tion, pre­mar­ket no­ti­fi­ca­tion and de novo reg­u­la­tory path­ways. The de­vice in­dus­try has com­plained about slow re­view times. How­ever, ear­lier this year, Dr. Jef­frey Shuren, di­rec­tor of the FDA’s Cen­ter for De­vices and Ra­di­o­log­i­cal Health, told mem­bers of Congress that one way for the agency to im­prove re­view times would be bet­ter sub­mis­sions from man­u­fac­tur­ers.

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