FDA tak­ing a long-term look at de­vice safety

Modern Healthcare - - Regulation - By Rachel Z. Arndt

The Food and Drug Ad­min­is­tra­tion ap­pears to be tak­ing a proac­tive and long-term ap­proach to­ward im­prov­ing med­i­cal-de­vice safety.

The FDA last week re­leased its Med­i­cal De­vice Safety Ac­tion Plan, in which reg­u­la­tors set out their goals for im­prov­ing de­vice safety, in­clud­ing track­ing a prod­uct’s per­for­mance through­out its life cy­cle and spark­ing in­no­va­tion.

The FDA’s cur­rent reg­u­la­tory frame­work for de­vices is from the mid-1970s.

“Safety is an area where there are def­i­nitely gaps in de­vice reg­u­la­tion,” said Jim She­han, se­nior counsel with Lowen­stein San­dler and chair of the firm’s FDA reg- ula­tory prac­tice. “The FDA is try­ing to make the pic­ture bet­ter, given the statu­tory tools that cur­rently ex­ist.”

Up­dates in the plan in­clude po­ten­tial ini­tia­tives for mak­ing sure med­i­cal de­vices are safe, in­clud­ing push­ing stronger cy­ber­se­cu­rity and a unique de­vice iden­ti­fi­ca­tion sys­tem that would track med­i­cal de­vices as they’re dis­trib­uted and used.

But reg­u­la­tors don’t ex­plain how the unique de­vice iden­ti­fi­ca­tion sys­tem would work with ex­ist­ing de­vices. “The doc­u­ment in gen­eral does not ad­dress the cur­rent in-mar­ket de­vices ad­e­quately,” said Dan Dod­son, pres­i­dent of con­sult­ing firm For­ti­fied Health Se­cu­rity.

In terms of look­ing ahead, FDA Com­mis­sioner Dr. Scott Got­tlieb and his fel­low reg­u­la­tors want to en­cour­age in­no­va­tion in de­vice safety.

The agency al­ready sup- ports that goal with the Break­through De­vice Pro­gram, es­tab­lished by the 21st Cen­tury Cures Act to speed up pa­tient ac­cess to treat­ments for cer­tain se­ri­ous con­di­tions.

On cy­ber­se­cu­rity, the FDA will con­sider re­quir­ing man­u­fac­tur­ers to en­able patch­ing of their de­vices from the get-go. The agency will also con­sider re­quir­ing com­pa­nies to give the agency and users a soft­ware bill of ma­te­ri­als, which would help users bet­ter man­age their de­vices and the de­vices’ soft­ware.

The agency could, in the fu­ture, re­quire man­u­fac­tur­ers to dis­close when vul­ner­a­bil­i­ties arise, ac­cord­ing to the plan. This fills an im­por­tant gap, said Beth Pit­man, an at­tor­ney with Waller Lans­den Dortch and Davis. Just as HIPAA se­cu­rity rules ap­ply to providers, so should sim­i­lar rules for med­i­cal-de­vice man­u­fac­tur­ers, she said.

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