Multiple Violations in Illegal Marketing of SeniorLife.AI

A 3/24-3/26 FDA inspection at SeniorLife Technologies in Bellevue, WA, determined that the firm is illegally marketing its SeniorLife.AI mobile application, intended to use artificial intelligence-based algorithms to screen and “pre-diagnose” mobility and cognitive health conditions. A just-released 8/21 Warning Letter says the firm lacks an approved PMA or IDE for its product and also did not notify the agency of its intent to introduce the device into commercial distribution.

FDA says SeniorLife registered its device under a regulation for Measuring Exercise Equipment, but the inspection found that SeniorLife.AI is intended for uses that are different from those of legally marketed devices classified as measuring exercise equipment.

“Use of artificial intelligence-based algorithms to screen and diagnose mobility and cognitive health conditions, including Alzheimer’s, are diagnostic functions that are not the same as measurement of exercises,” FDA says. “Performing proprietary analyses of patient data for the screening and diagnosis of specific conditions or disorders represents a new intended use compared to use in rehabilitation or physiotherapy to provide or facilitate exercise rehabilitation and to include exercise measurement capabilities, such as for redevelopment of muscles for restoration of motion and providing accompanying measurement of range of motion.”

The letter also cites these Quality System Regulation and Medical Device Reporting violations:

• failure to adequately establish procedures for corrective and preventive action;
• failure to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
• failure to establish procedures for quality audits;
• failure to establish procedures for training and identifying training needs;
• failure to develop a written Medical Device Reporting procedure; and
• failure or refusal to furnish any material or information required by regulations, including adverse event reports.

The device is also misbranded, the letter says, because the product’s Web site contains representations creating a false and misleading impression of official approval of the device and potential endorsement by FDA.

SeniorLife was told to act promptly to correct the violations and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation of the corrections and a schedule for completing them.

“The specific violations noted in this letter and in the … FDA 483 issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems,” the letter concludes. “Your firm should investigate and determine the causes of the violations and take prompt actions to correct the violations and bring the products into compliance.”