FDA releases first Artificial Intelligence (AI) regulatory plan to promote responsible digital health innovation

FDA Releas­es Arti­fi­cial Intelligence/Machine Learn­ing Action Plan (FDA press release):

Today, the U.S. Food and Drug Admin­is­tra­tion released the agency’s first Arti­fi­cial Intelligence/Machine Learn­ing (AI/ML)-Based Soft­ware as a Med­ical Device (SaMD) Action Plan. This action plan describes a mul­ti-pronged approach to advance the Agency’s over­sight of AI/ML-based med­ical soft­ware … The AI/ML-Based Soft­ware as a Med­ical Device Action Plan out­lines five actions that the FDA intends to take, including:

• Fur­ther devel­op­ing the pro­posed reg­u­la­to­ry frame­work, includ­ing through issuance of draft guid­ance on a pre­de­ter­mined change con­trol plan (for software’s learn­ing over time);

• Sup­port­ing the devel­op­ment of good machine learn­ing prac­tices to eval­u­ate and improve machine learn­ing algorithms;
• Fos­ter­ing a patient-cen­tered approach, includ­ing device trans­paren­cy to users;
• Devel­op­ing meth­ods to eval­u­ate and improve machine learn­ing algo­rithms; and
• Advanc­ing real-world per­for­mance mon­i­tor­ing pilots.

Launched in Sep­tem­ber of 2020, the CDRH Dig­i­tal Health Cen­ter of Excel­lence is com­mit­ted to strate­gi­cal­ly advanc­ing sci­ence and evi­dence for dig­i­tal health tech­nolo­gies with­in the frame­work of the FDA’s reg­u­la­to­ry and over­sight role. The goal of the Cen­ter is to empow­er stake­hold­ers to advance health care by fos­ter­ing respon­si­ble and high-qual­i­ty dig­i­tal health innovation.

The Action Plan:

• Title: Arti­fi­cial Intel­li­gence and Machine Learn­ing in Soft­ware as a Med­ical Device
• Descrip­tion: The U.S. Food and Drug Admin­is­tra­tion (FDA) issued the “Arti­fi­cial Intelligence/Machine Learn­ing (AI/ML)-Based Soft­ware as a Med­ical Device (SaMD) Action Plan” from the Cen­ter for Devices and Radi­o­log­i­cal Health’s Dig­i­tal Health Cen­ter of Excel­lence. The Action Plan is a direct response to stake­hold­er feed­back to the April 2019 dis­cus­sion paper, “Pro­posed Reg­u­la­to­ry Frame­work for Mod­i­fi­ca­tions to Arti­fi­cial Intelligence/Machine Learn­ing-Based Soft­ware as a Med­ical Device” and out­lines five actions the FDA intends to take.
• To Learn More and Down­load: click HERE

News in Context: 5 digital health innovations cleared by the FDA in 2020

• Novem­ber: FDA grants clear­ance for Night­Ware app designed to reduce PTSD-relat­ed nightmares
• Octo­ber: The FDA clears Applied­VR head­set to help treat fibromyal­gia and chron­ic pain
• August: Neu­ro­mod­u­la­tion device Reliv­ion gets FDA clear­ance to help patients with major depres­sion who don’t ben­e­fit from anti­de­pres­sant medications
• June: FDA clears first videogame to be pre­scribed to kids with ADHD: Endeav­or­Rx by Akili Inter­ac­tive Labs
• May: Portable brain assess­ment device by Head­safe secures 510(k) FDA clearance
• A call to action: We need the right incen­tives to guide eth­i­cal inno­va­tion in neu­rotech and healthcare