3B Medical, Inc. dba Reach Health, Inc.: FDA Warning Letter (May 20, 2026)

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1
Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit to ensure that all complaints are processed in a uniform and timely manner and complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803 or 804 of this chapter, Medical Device Reporting (MDR), as required by 21 CFR 820.198(a), 820.198(a)(1), and 820.198(a)(3).

Passage 2
Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).

Passage 3
Failure to establish and maintain procedures for validating the device design, including risk analysis, as required by 21 CFR 820.30(g).

Passage 4
Failure to establish and maintain procedures to ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b).

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

21 CFR 806.10
21 CFR 806
21 CFR 807.81(a)(3)
21 CFR 807.81(b)
21 CFR 807.81(a)(3)(i)
21 CFR 820.198(a)
21 CFR 820.100(a)(1)
21 CFR 820
21 CFR 820.198(a)(3)
21 CFR 820.198(a)(1)
21 CFR 820.100(a)
21 CFR 820.30(g)
21 CFR 820.25(b)