Effective Date of Requirement for Premarket Approval for Blood Lancets
Information
Type
Proposed Rule
Regulated products
Published
March 3, 2016
Last updated
March 3, 2016
Description
Document number 2016-04579. The Food and Drug Administration (FDA) is issuing a proposed administrative order to require the filing of a premarket approval application (PMA) following the reclassification of multiple use blood lancets for multiple patient use from class I to class III. FDA is summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring this device to meet the PMA requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and the benefits to the public from the use of the device.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)