Com­pa­nies ask FDA for reg­u­la­tion, im­prove­ment of da­ta col­lec­tion from dig­i­tal health de­vices

The FDA should con­sid­er reg­u­lat­ing how da­ta gath­ered from dig­i­tal health de­vices like con­tin­u­ous glu­cose mon­i­tors and sen­sors are in­cor­po­rat­ed in­to clin­i­cal-tri­al sub­mis­sions, ac­cord­ing to sev­er­al com­ment let­ters from mul­ti­ple ad­vo­cate and in­dus­try or­ga­ni­za­tions.

At least five or­ga­ni­za­tions have sub­mit­ted pub­lic com­ments on the FDA’s pro­pos­al ex­am­in­ing how best to use dig­i­tal health tech­nolo­gies (DHTs) in drug and bi­o­log­ic de­vel­op­ment, par­tic­u­lar­ly in de­cen­tral­ized clin­i­cal tri­als.

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