FDA WARNING_LETTER - Life Technologies - March 26, 2025

SeniorLife Technologies, Inc., located at 1400 112th Ave., Bellevue, WA, was inspected by the FDA from March 24 to March 26, 2025. The inspection identified significant regulatory violations concerning their product, SeniorLife.AI, a mobile application intended for diagnosing mobility and cognitive health conditions.

Key violations include:

1. **Unapproved Device**: SeniorLife.AI is classified as a medical device under section 201(h) of the Federal Food, Drug, and Cosmetic Act. It is considered adulterated because the company lacks an approved premarket approval (PMA) or investigational device exemption (IDE). Additionally, the device is misbranded due to the absence of a 510(k) notification, as required by the Act.

2. **Quality System Regulation Violations**: The firm failed to comply with current good manufacturing practices under 21 CFR Part 820. Specific issues include inadequate procedures for corrective and preventive actions, complaint handling, quality audits, and employee training.

3. **Medical Device Reporting (MDR) Violations**: The company did not develop or maintain proper MDR procedures as required by 21 CFR 803.17.

The FDA has requested that SeniorLife Technologies, Inc. cease activities leading to the misbranding or adulteration of the SeniorLife.AI device. The company must address these violations by submitting the necessary documentation for device approval or clearance and implementing compliant quality system practices. The FDA awaits a response to the Form FDA 483 issued during the inspection, detailing corrective actions to resolve these issues.