Effective Date of Requirement for Premarket Approval for Blood Lancets
Information
Type
Rule
Regulated products
Published
November 22, 2021
Last updated
November 22, 2021
Description
Document number 2021-25381. The Food and Drug Administration (FDA, Agency, or we) is issuing a final order to require the filing of a premarket approval application (PMA) or notice of completion of a product development protocol (PDP) following the reclassification of multiple use blood lancets for multiple patient use from class I to class III.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)