Effective Date of Requirement for Premarket Approval for Blood Lancets
fda-device · Food and Drug Administration · Rule · Published 2021-11-22 · Effective 2021-11-22 · 86 FR 66177
Document
Document number
2021-25381
Federal Register citation
86 FR 66177
CFR reference
21 CFR 878
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2021-11-22
Effective date
2021-11-22
HHS docket
Docket No. FDA-2016-M-0035
Abstract
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.