Tip for digital health start-ups: To navigate regulatory gray areas, “engage early and engage often” with the FDA

by

FDA’s enforce­ment dis­cre­tion for dig­i­tal health is more ambigu­ous than ever in 2021 (Mobi­Health­News):

The dig­i­tal health ecosys­tem has swelled to encom­pass a broad range of prod­ucts over the years.

On one end of the spec­trum is soft­ware-as-med­ical-devices (SaMD) and pre­scrip­tion dig­i­tal ther­a­peu­tics, prod­uct cat­e­gories for which a com­pre­hen­sive reg­u­la­to­ry strat­e­gy and engage­ment with the FDA are manda­to­ry. On the oth­er are well­ness apps and oth­er low-risk dig­i­tal tools that like­ly spend more time wor­ry­ing about over­sight from the Fed­er­al Trade Com­mis­sion than the health regulator.

How­ev­er, a grow­ing num­ber of com­pa­nies are find­ing them­selves in a gray area of enforce­ment dis­cre­tion, a term the FDA uses for low­er-risk prod­ucts that meet the def­i­n­i­tion of a med­ical device, but do not require reg­u­la­to­ry sub­mis­sion, review and autho­riza­tion before head­ing to mar­ket … Ear­ly-stage com­pa­nies that haven’t yet inter­nal­ized these con­cepts of doc­u­men­ta­tion and trans­paren­cy should take an “engage ear­ly and engage often” approach with the FDA, Cruz said (Edi­tor’s Note: Marisa Cruz, EVP of reg­u­la­to­ry and clin­i­cal affairs at Ever­ly­well, and for­mer­ly a senior med­ical advi­sor for dig­i­tal health at FDA’s Cen­ter for Devices and Radi­o­log­i­cal Health). These con­ver­sa­tions can help new­com­ers adopt appro­pri­ate prac­tices ear­ly in the pro­duc­t’s life cycle, regard­less of whether or not they’ll even­tu­al­ly require a reg­u­la­to­ry submission.

“The sense that you got it wrong, that the agency did­n’t know about it, that there were no con­ver­sa­tions, can some­times poor­ly posi­tion a start­up com­pa­ny, where­as I think proac­tive engage­ment (‘This is my plan. Do you agree with the con­cept? We’ll keep you apprised as things change.’) can be a foun­da­tion for a more pro­duc­tive rela­tion­ship,” she said.

About the Panel:

How do we Define Enforce­ment Dis­cre­tion Exact­ly? over at DTx West:

This inter­ac­tive, dis­cus­sion-led ses­sion will enable you to deep­en your under­stand­ing of enforce­ment dis­cre­tion reg­u­la­tion. Share your insights, pose your ques­tions to the group or sim­ply lis­ten in to the con­ver­sa­tion, the choice is yours. Kick­starter dis­cus­sions include:

  • A dis­cus­sion on what exact­ly enforce­ment dis­cre­tion is
  • How can we ensure we are stay­ing with­in the guide­lines when so many are unsure of where they lie?
  • Under­stand­ing how best to work the reg­u­la­to­ry bod­ies to out­line exact­ly what is required

Mod­er­at­ed By: Kal Patel, Co-Founder & CEO, BrightInsight

  • Aca­cia Parks, Chief Sci­ence Offi­cer, Hap­pi­fy Health
  • Marisa Cruz, Chief Med­ical Offi­cer, Limbix
  • Lucia Sav­age, Chief Pri­va­cy and Reg­u­la­to­ry Offi­cer, Oma­da Health
  • Ankur Kaushal, VP, Reg­u­la­to­ry Affairs & Qual­i­ty, Big Health
  • Susan Baum­gart­ner, VP, Prod­uct Man­age­ment & Reg­u­la­to­ry Affairs, etectRx

News in Context: