FDA of­fers plan to im­prove post-mar­ket sur­veil­lance

Modern Healthcare - - LATE NEWS -

The U.S. Food and Drug Ad­min­is­tra­tion said in a new re­port that it plans to im­prove its post-mar­ket sur­veil­lance sys­tem for med­i­cal de­vices, in part by es­tab­lish­ing a unique de­vice iden­ti­fi­ca­tion sys­tem. The FDA’s Cen­ter for De­vices and Ra­di­o­log­i­cal Health pro­posed four ini­tia­tives to im­prove its post-mar­ket sur­veil­lance of de­vices: es­tab­lish­ing a UDI sys­tem that can in­te­grate with elec­tronic health records; pro­mot­ing the de­vel­op­ment of na­tional and in­ter­na­tional reg­istries for cer­tain de­vices; mod­ern­iz­ing ad­verse-event re­port­ing and anal­y­sis; and de­vel­op­ing new meth­ods for ev­i­dence gen­er­a­tion, syn­the­sis and ap­praisal. Some of the pro­posed ac­tions are in progress. Ear­lier this sum­mer, the FDA is­sued its lon­gawaited pro­posed rule on the UDI sys­tem, which will re­quire man­u­fac­tur­ers to be­gin mark­ing the la­bel and pack­ag­ing of high-risk de­vices with unique iden­ti­fiers within one year of the fi­nal rule tak­ing ef­fect. Last year, the In­sti­tute of Medicine rec­om­mended that the FDA de­velop a post-mar­ket sur­veil­lance strat­egy that will bet­ter use post-mar­ket per­for­mance data of de­vices. The FDA plans to hold four pub­lic meet­ings on the pro­posed ini­tia­tives this month and is also ac­cept­ing com­ments on­line.

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