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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

ExThera Medical Corporation

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 obtain FDA approval prior to implementing a change to the investigational plan [21 CFR 812.35(a)(1)].

Passage 2

Failure to ensure proper monitoring of the investigation and failure to secure clinical investigator’s compliance with investigational plans [21 CFR 812.40, 21 CFR 812.46(a)].

Citations in the original letter

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

  • 21 CFR 807.81
  • 21 CFR 807.81(b)
  • 21 CFR 812.35(a)(1)
  • 21 CFR 812.35(a)(2)
  • 21 CFR 812.40
  • 21 CFR 812.46(a)
  • 21 CFR 812.5(b)
  • 21 CFR 812.7