BMC Medical Co., Ltd.

Selected passages from the FDA letter

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

Passage 1

FDA's regulations at 21 CFR 807.81(a)(3)(i) provide that submission of a 510(k) is required for "a change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process." Thus, the G3X APAP is misbranded under 502(o) because of your failure to submit the required premarket notification for the modifications.

Passage 2

Failure to submit a Report required by 21 CFR 806.10 to FDA, within 10 working days of initiating the correction or removal. For example: your Luna G3 APAP devices with firmware G3-2.00.76 could cause the Luna G3 APAP device to unexpectedly shut down during use, which causes loss of therapy for patients with obstructive sleep apnea. You communicated with 3B (React Health) in **(b)(4)** to **(b)(4)**. The action of updating the firmware to G3-2.00.77 is a medical device correction or removal initiated to reduce a risk to health posed by the device or to remedy a violation of the Act caused by the device which may present a risk to health, for which you are required to submit a Report of Correction or Removal to FDA.