501(K) PROCESS CALLED FLAWED /

Modern Healthcare - - Front Page -

An IOM com­mit­tee rec­om­mends the FDA scrap it and in­vest in a process that as­sures safety.

An In­sti­tute of Medicine com­mit­tee rec­om­mended that the Food and Drug Ad­min­is­tra­tion scrap its 510(k) process, a fast-track av­enue avail­able to med­i­cal de­vices that are “sub­stan­tially equiv­a­lent” to an­other de­vice al­ready on the mar­ket, or to one cleared be­fore 1976. The re­port con­cluded the process is too flawed to fix and the “FDA’s fi­nite re­sources would be bet­ter in­vested in de­vel­op­ing an in­te­grated pre­mar­ket and post-mar­ket reg­u­la­tory frame­work that pro­vides a rea­son­able as­sur­ance of safety and ef­fec­tive­ness through­out the de­vice life cy­cle.” The re­port con­cluded that a 510(k) clear­ance does not show that a com­pa­ra­ble de­vice is safe or ef­fec­tive be­cause the ma­jor­ity of de­vices used as the ba­sis for com­par­i­son were not re­viewed for safety or ef­fec­tive­ness. The FDA, as well as the Ad­vanced Med­i­cal Tech­nol­ogy As­so­ci­a­tion, which rep­re­sents de­vice­mak­ers, and the Med­i­cal Imag­ing and Tech­nol­ogy Al­liance said in sep­a­rate state­ments that they do not sup­port the IOM’s rec­om­men­da­tion. The 510(k) process has been an on­go­ing is­sue in Wash­ing­ton, with pol­i­cy­mak­ers and pa­tient groups rais­ing con­cerns about safety, while in­dus­try ar­gues that the FDA’s ap­proval process has be­come in­creas­ingly un­pre­dictable.

GETTY IM­AGES De­vices can be fast-tracked if they are “sub­stan­tially equiv­a­lent” to an­other de­vice on the mar­ket.

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