Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g). Specifically, your firm failed to validate the use and integration of the **(b)(4)** software and **(b)(4)** panels used in the Micro-X Rover Mobile X-ray System MXU-RV71. Your firm failed to document justification for the decision not to validate.
Passage 2Failure to adequately establish and maintain procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). Specifically, Quality Event and CAPA procedure, SOP006, fails to require that appropriate statistical methodology be employed where necessary to detect recurring quality problems, in order to identify existing and potential causes of nonconforming product.
Passage 3Failure to report a medical device correction or removal to FDA, initiated to remedy a violation which may present a risk to health, as required by 21 CFR 806.10(a). Specifically, your firm failed to report the following 2 field corrections conducted to reduce a risk to health posed by Micro-X Rover Mobile X-ray Systems:
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 1000
- 21 CFR 1002.20
- 21 CFR 1003.2(b)(1)
- 21 CFR 1003.20
- 21 CFR 1003.10(a)
- 21 CFR 1010
- 21 CFR 1020.31(a)(4)
- 21 CFR 1020.30(h)(3)
- 21 CFR 803
- 21 CFR 806.10(a)
- 21 CFR 806
- 21 CFR 820.30(i)
- 21 CFR 820.30(g)
- 21 CFR 820.100(a)
- 21 CFR 820.198(a)(3)