FDA bol­sters process for OK’ing ra­di­a­tion de­vices

Modern Healthcare - - Late News -

In the wake of re­cent safety prob­lems, the Food and Drug Ad­min­is­tra­tion has an­nounced plans to strengthen its ap­proval process for ra­di­a­tion ther­apy equip­ment (April 5, p. 14). The new, more rig­or­ous stan­dards were al­luded to in a let­ter to ra­di­a­tion de­vice man­u­fac­tur­ers from Jef­frey Shuren, di­rec­tor of the FDA’s Cen­ter for De­vices and Ra­di­o­log­i­cal Health. In the let­ter, Shuren at­trib­uted many of the re­ported prob­lems as­so­ci­ated with ra­di­a­tion ther­apy to a lack of ad­e­quate safety mea­sures. The FDA ar­rived at its con­clu­sions us­ing data from more than 1,100 med­i­cal-de­vice re­ports, which are used to de­scribe ad­verse events. More in­for­ma­tion re­gard­ing spe­cific changes to ap­proval pro­to­col, pre­mar­ket test­ing and re­view will fol­low in an of­fi­cial no­tice, the agency said. Ad­di­tion­ally, the FDA plans to hold a pub­lic work­shop where man­u­fac­tur­ers can learn more about the changes.

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