Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1your firm failed to document an assessment of the risk of the affected units in the field for this issue, when investigating the cause of nonconformities relating to the product.
Passage 2the risk analysis for MobileDiagnost wDR (Document IH0532RA_Annex, dated April 26, 2022) fails to include this increased hazard severity (life threatening) to ensure that appropriate risk control measures are implemented.
Passage 3your firm failed to submit a report of correction or removal to FDA for these actions.
Passage 4the wDR2.2 was approved and released for distribution in the US without documentation to show that the required performance standard checklist (Technical Report Subchapter J of 21 CFR MobileDiagnost wDR 2.2, Doc #R01005_21CKL) was completed to demonstrate compliance with the performance standard requirements prior to release of the product. The performance standard checklist was not completed until Jan. 14, 2025.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 1000
- 21 CFR 1002.30(a)(1)
- 21 CFR 1020.30
- 21 CFR 806.10
- 21 CFR 806
- 21 CFR 820.100(a)
- 21 CFR 820.30(g)