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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

Sonesta Medical AB

Issued · Posted by FDA

FDA published a close-out letter on Feb 28, 2024. The passages below are from the original warning letter.

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 establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient, as required by 21 CFR 820.30(c). Specifically, your firm does not have procedures for defining a mechanism to resolve incomplete, ambiguous, or conflicting design requirements.

Citations in the original letter

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

  • 21 CFR 820.50(a)
  • 21 CFR 820.198(a)
  • 21 CFR 820.30(c)
  • 21 CFR 820.30(g)
  • 21 CFR 820.30(i)
  • 21 CFR 820.40