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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

Royal Philips

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 submit a written report of a correction or removal of a device to FDA, initiated to reduce a risk to health or to remedy a violation which may present a risk to health, as required by 21 CFR 806.10. Specifically, your firm failed to report to FDA field corrections conducted to reduce the following risks to health:

Citations in the original letter

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

  • 21 CFR 806
  • 21 CFR 806.10
  • 21 CFR 820.50(a)(2)