The FDA is taking a closer look at blood sampling devices to determine whether the technology merits a higher level of regulatory oversight.
Currently classified as class I, blood lancets are only subject to general regulatory control. However, the FDA will host an advisory committee meeting on June 26 to determine whether blood lancets merit class II or class III regulatory status. The committee will offer its recommendation to the FDA based on the scientific data presented.
A blood lancet is a sampling device with a needle at the tip, intended for blood diagnostics. There are currently four subsets of blood lancets indicated for single-use and multiple-use configurations.
The meeting will be held in Gaithersburg, Maryland, and will be open to the public. The FDA will publish background material, such as proceedings and scientific evidence, at least 48 hours before the meeting, according to a regulatory notice.
