Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1However, we disagree with this assessment because adding the Silence Alarms function is a change to a control mechanism of the device and we believe that “Yes” should have been selected, leading to “New 510(k).” The addition of a Silence Alarms function is a change to a control mechanism because it modifies the manner in which the user controls the device, which could result in the alarms not operating as the user intends. This change may result in missed alarms for life-threatening conditions that require immediate attention, leading to patient harm such as serious injury and/or death. As such, the modification of the device is a change or modification in the device that could significantly affect its safety or effectiveness and requires submission of a 510(k) under 21 CFR 807.81(a)(3)(i).
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 807.81(b)(1)(i)
- 21 CFR 807.81(a)(3)(i)
- 21 CFR 807.81(a)(3)(ii)
- 21 CFR 870.1025