The FDA ends precertification (Pre-Cert) pilot program, saying new authority required to regulate software as a medical device (SaMD)

FDA acknowl­edges short­com­ings of Pre-Cert pilot in report (Reg­u­la­to­ry Focus):

The US Food and Drug Admin­is­tra­tion (FDA) said it needs addi­tion­al Con­gres­sion­al author­i­ty to move for­ward with its dig­i­tal health pre­cer­ti­fi­ca­tion (Pre-Cert) pro­gram. While the idea has been wide­ly laud­ed by var­i­ous stake­hold­ers, at least one expert said he feels vin­di­cat­ed for warn­ing the agency ear­ly on that it lacked the legal author­i­ty to ful­ly imple­ment pathway.

In 2017, the FDA pro­posed the idea of a Pre-Cert pro­gram that would act as a new path­way for soft­ware as a med­ical device (SaMD) prod­ucts, through which the agency could green-light such prod­ucts based on how much reg­u­la­tors trust the man­u­fac­tur­er. The agency has been run­ning a pilot pro­gram to test the fea­si­bil­i­ty of the pro­gram, but in a new report, FDA con­cedes it does not have the legal author­i­ty need­ed to cre­ate the pro­gram as orig­i­nal­ly envisioned.

… “We are not ful­ly cap­i­tal­iz­ing on these capa­bil­i­ties and approach­es for soft­ware in the cur­rent statu­to­ry and reg­u­la­to­ry frame­work for med­ical devices,” said FDA. “Based on these obser­va­tions from the pilot, FDA has found that rapid­ly evolv­ing tech­nolo­gies in the mod­ern med­ical device land­scape could ben­e­fit from a new reg­u­la­to­ry par­a­digm, which would require a leg­isla­tive change.”

“Giv­en the chal­lenges faced dur­ing the pilot, FDA has deter­mined that the approach described in the Work­ing Mod­el is not prac­ti­cal to imple­ment under our cur­rent statu­to­ry and reg­u­la­to­ry author­i­ties,” the agency added. “How­ev­er, the pilot informed what new statu­to­ry author­i­ties could sup­port a future reg­u­la­to­ry par­a­digm that builds on these concepts.”

Q&A: The FDA’s chal­lenge in reg­u­lat­ing evolv­ing dig­i­tal health tools (Mobi­Health­News):

David Rosen, a part­ner and pub­lic pol­i­cy lawyer at Foley & Lard­ner, notes there have been big changes in the dig­i­tal health space in the past five years, includ­ing advances in con­sumer wear­ables and tools that aim to guide clin­i­cian deci­sion-mak­ing. He sat down with Mobi­Health­News to dis­cuss the Pre-Cert pilot pro­gram and how dig­i­tal health com­pa­nies should approach the reg­u­la­to­ry process.

Mobi­Health­News: What were some of your big take­aways from the Pre-Cert pilot?

David Rosen: The whole idea behind the Pre-Cert pro­gram was to look at dif­fer­ent reg­u­la­to­ry approach­es to try to assist com­pa­nies in devel­op­ing soft­ware for use as a med­ical device. And it was pred­i­cat­ed on com­pa­nies mak­ing sure that they have a robust qual­i­ty orga­ni­za­tion and orga­ni­za­tion­al excel­lence, and that they do some real-world mon­i­tor­ing of the soft­ware as it’s being used.

In gen­er­al, I think that’s a very appro­pri­ate goal and a good goal for the FDA to con­sid­er, because this is the evo­lu­tion of how health­care is being deliv­ered. The mod­el is evolv­ing, and we have this new par­a­digm, and I think the FDA has to be open to shift­ing how they reg­u­late things out­side of the nor­mal scope of tra­di­tion­al med­ical devices that they typ­i­cal­ly see … the bot­tom line is that the FDA decid­ed that the cur­rent reg­u­la­to­ry par­a­digm isn’t going to work for this, and that they need a dif­fer­ent FDA reg­u­la­to­ry path­way and review process to deal with soft­ware as a med­ical device.

MHN: So what do you think dig­i­tal health and health tech com­pa­nies should take from this pro­gram and these results?

Rosen: First, they need to watch what the FDA is going to be doing in the future. This cul­ture of qual­i­ty and orga­ni­za­tion­al excel­lence though, in terms of ver­i­fi­ca­tion and val­i­da­tion of soft­ware, is real­ly, real­ly important.

I’ve worked on a lot of these prod­ucts, and you see com­pa­nies have dif­fer­ent approach­es in how they want to ver­i­fy and val­i­date the use­ful­ness of the data. And I think that we have to be very cir­cum­spect, and the com­pa­nies have to be very cir­cum­spect, and they need to work and edu­cate the FDA on how their pro­gram works and why the met­rics are appro­pri­ate­ly valid to come up with some sort of treat­ment deci­sion. It needs to be a coop­er­a­tive approach between the indus­try and FDA to move this whole sit­u­a­tion for­ward to help bring new prod­ucts into the marketplace.

To Learn More:

• Down­load full FDA report HERE, titled The Soft­ware Pre­cer­ti­fi­ca­tion (Pre-Cert) Pilot Pro­gram: Tai­lored Total Prod­uct Life­cy­cle Approach­es and Key Find­ings (opens PDF)
• A con­ver­sa­tion at the fron­tier of dig­i­tal health inno­va­tion, FDA reg­u­la­tions, and cog­ni­tive health
• A call to action: We need the right incen­tives to guide eth­i­cal inno­va­tion in neu­rotech and healthcare
• The FDA cre­ates new Dig­i­tal Health unit to reimag­ine reg­u­la­to­ry paths in the age of scal­able, AI-enhanced innovation