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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

Envoy Medical Inc.

Issued · Posted by FDA

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 and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).

Passage 2

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

Passage 3

Failure to adequately establish and maintain design validation procedures to ensure proper risk analysis is completed, as required by 21 CFR 820.30(g).

Citations in the original letter

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

  • 21 CFR 820.198(a)
  • 21 CFR 820.100(a)
  • 21 CFR 820.30(g)