US Food and Drug Administration

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

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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. [Read more…] about The FDA ends pre­cer­ti­fi­ca­tion (Pre-Cert) pilot pro­gram, say­ing new author­i­ty required to reg­u­late soft­ware as a med­ical device (SaMD)

Transcranial Direct Current Stimulation shows early promise to ameliorate depression, especially if combined with other therapies and dosage optimized

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Tran­scra­nial Direct Cur­rent Stim­u­la­tion Promis­ing for Major Depres­sive Dis­or­der (Psy­chi­a­try Advisor):

“Tran­scra­nial direct cur­rent stim­u­la­tion (tDCS) is an inves­tiga­tive modal­i­ty for major depres­sive dis­or­der (MDD) that has shown some promis­ing results. Though it has a while before it is approved by the US Food and Drug Admin­is­tra­tion, clin­i­cians and patients have been clam­or­ing for an effec­tive treat­ment for MDD that is not asso­ci­at­ed with harm­ful adverse effects. [Read more…] about Tran­scra­nial Direct Cur­rent Stim­u­la­tion shows ear­ly promise to ame­lio­rate depres­sion, espe­cial­ly if com­bined with oth­er ther­a­pies and dosage optimized