ZYTO Technologies, Inc.: FDA Warning Letter (Jun 21, 2023)

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 adequately establish procedures for design controls, as required by 21 CFR 820.30.

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

Passage 3
Failure to adequately establish procedures for complaint handling per the requirements of 21 CFR Part 820.198, including an evaluation to determine reportability under 21 CFR Part 803 (Medical Device Reporting), and to document complaint investigations or a record including the reason when no investigation is performed.

Passage 4
Failure to adequately establish a procedure to ensure DHRs are maintained to demonstrate the device is manufactured in accordance with the DMR, per the requirements of 21 CFR Part 820.184.

Passage 5
Failure to develop, maintain, and implement written labeling procedures to control UDI labeling activities pursuant to 21 CFR 820.120.

Citations in the original letter

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

21 CFR 803
21 CFR 807.81(b)
21 CFR 820.30
21 CFR 820.30(e)
21 CFR 820.198
21 CFR 820.184
21 CFR 820.30(f)
21 CFR 820.100(a)
21 CFR 820.100(a)(2)
21 CFR 820.100(a)(4)
21 CFR 820.198(a)(3)
21 CFR 820.198(b)
21 CFR 820.3(b)
21 CFR 820.120
21 CFR 882.1540
21 CFR 882.9(a)