ICU Medical

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

your firm has failed to submit a premarket notification submission to FDA for significant changes or modifications that could significantly affect the safety or effectiveness of these devices, as required by 21 CFR 807.81(a)(3)(i).

Passage 2

you have not yet submitted 510(k)s as required by 21 CFR 807.81(a)(3)(i).

Passage 3

The changes that you made to the risk control measures in an effort to mitigate the hazards that were the basis for a Class I recall were not submitted to FDA in a required 510(k) even though your own procedure indicates that submission of a 510(k) would be required in this situation.