FDA’s Pre-Certification Public Workshop: Top Line Take Aways from a Digital Health Innovator

Anand K. Iyer, PhD, MBA
March 8, 2018

In mid-2017, the U.S. Food and Drug Admin­is­tra­tion (FDA) pub­lished the Dig­i­tal Health Inno­va­tion Action Plan. At the same time FDA’s cur­rent Com­mis­sion­er, Scott Got­tleib, MD, launched the Soft­ware Pre­cer­ti­fi­ca­tion Pilot Pro­gram, sim­ply called Pre-Cer­ti­fi­ca­tion or Pre-Cert pro­gram.

Uniqueness’s of Digital Health Technologies

This pro­gram, devel­oped under FDA’s Cen­ter for Cen­ter for Devices and Radi­o­log­i­cal Health (CDRH), rec­og­nizes the uniqueness’s of dig­i­tal health tech­nolo­gies, in their promise to improve the health of the pub­lic and the fre­quent iter­a­tive process of prod­uct improve­ments. A key aim of Pre-Cert is to assure deliv­ery and access to high-qual­i­ty, safe and effec­tive dig­i­tal health prod­ucts in a time­li­er and less bur­den­some process.

FDA’s Steps to Create Pre-Cert

To cre­ate Pre-Cert, FDA is con­duct­ing a pilot with nine com­pa­nies (link: The pilot, con­sid­ered a first step in this process, is designed to col­lab­o­rate with the full ecosys­tem of stake­hold­ers to achieve suc­cess. Phase 1 includ­ed site vis­its to the pilot orga­ni­za­tions. Phase 2 was a pub­lic work­shop, Fos­ter­ing Dig­i­tal Health Inno­va­tion: Devel­op­ing the Soft­ware Pre­cer­ti­fi­ca­tion Pro­gram, held Jan­u­ary 30–31, 2018.

Public Workshop on Pre-Cert

This pub­lic work­shop delved into the program’s progress and sought input from the nine pilot play­ers on their visions for the Pre-Cert pro­gram. To be clear, these nine enti­ties were not cho­sen by FDA as the first to obtain Pre-Cert sta­tus, rather they’re help­ing to design the process FDA will put in place. Com­plete archives of the work­shop are avail­able (link:

Top Take Aways from Anand Iyer

Anand Iyer, PhD, MBA, WellDoc’s Chief Strat­e­gy Offi­cer, pre­sent­ed at and attend­ed this work­shop. He has been involved long term in the think­ing behind this inno­v­a­tive FDA pro­gram. He shares his top line take aways here:

  1. The FDA aspires to decrease the approval process cycle time to clear cer­tain low, and per­haps low-medi­um risk Soft­ware as a Med­ical Device prod­ucts (SaMD). So rather than FDA clear­ing every prod­uct or iter­a­tion of a prod­uct for which the enti­ty seeks FDA approval there would be a process to clear the dig­i­tal health developers/companies. To accom­plish this, FDA must devel­op a frame­work that includes a process, a key per­for­mance indi­ca­tor (KPI) score­card and a mech­a­nism for the enti­ty to earn ini­tial approval and main­tain their sta­tus over time.
  2. An ele­ment of this process requires the devel­op­ment of trans­par­ent met­rics. The five areas of trans­paren­cy FDA is look­ing at are: patient safe­ty, clin­i­cal respon­si­bil­i­ty, prod­uct qual­i­ty, cyber respon­si­bil­i­ty and proac­tive cul­ture. For each of these met­rics, FDA is seek­ing to under­stand best prac­tices and indus­try-accept­ed KPIs used to mea­sure excel­lence.
  3. Build­ing this Pre-Cert process is a dis­rup­tive move by a gov­ern­ment reg­u­la­to­ry agency (FDA in this case). It fun­da­men­tal­ly changes the rules of the game. But, it’s a “have your cake and eat it too” play on the part of FDA. It allows tech­nol­o­gy inno­va­tion to flour­ish at high­er speeds while main­tain­ing safe­ty and qual­i­ty as non-nego­tiable “pins in the sand­box.”
  4. By observ­ing the list of the nine com­pa­nies cho­sen by FDA to par­tic­i­pant in this pilot, it’s clear an objec­tive is to take inputs from enti­ties who’ve been involved in the device space a long time (e.g., JNJ, Medtron­ic) as well as to also learn from emer­gent play­ers (e.g., Apple, Google, Sam­sung) to arrive at a uni­fied pro­gram.
  5. In addi­tion to atten­dance by mem­bers of the nine pilot enti­ties, FDA very smart­ly also invit­ed sev­er­al stan­dards and qual­i­ty orga­ni­za­tions, such as the Euro­pean Qual­i­ty Asso­ci­a­tion, the U.S.-based Cen­ter for Medicare and Med­ic­aid Inno­va­tion (CMMI), Bal­anced Score­card and oth­ers.
  6. Sig­nif­i­cant work remains to syn­the­size the learn­ings from the work­shop to achieve the end goals of this pro­gram. Real­i­ty is this type of pro­gram has nev­er exist­ed. It’s not just a cut and paste from some­one or some­thing else. It has unique char­ac­ter­is­tics and con­straints.

 A com­pre­hen­sive FAQ on the pro­gram is avail­able.

Fol­low the evo­lu­tion of this nov­el pro­gram on Twit­ter at: #FDAPre­Cert

Check out the top line take aways from this pub­lic work­shop from dig­i­tal health clin­i­cian and researcher, Malin­da Peeples, RN, MS, CDE, WellDoc’s VP, Clin­i­cal Ser­vices, Pro­grams and Research.