Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling." FDA is issuing this guidance with labeling recommendations because of concerns that both healthcare providers and patients may be unaware of the serious adverse health risks associated with using the same blood lancet device for assisted withdrawal of blood from more than one patient, even when the lancet blade is changed for each blood draw. FDA recommends that all blood lancet devices be labeled for use only on a single patient. A statement limiting use to a single patient should also appear on the label attached to the device, if possible. The guidance document is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices.