Gastroenterology-Urology Devices; Reclassification of Implanted Blood Access Devices
fda-device · Food and Drug Administration · Rule · Published 2014-07-25 · Effective 2014-07-25 · 79 FR 43241
Document
Document number
2014-17477
Federal Register citation
79 FR 43241
CFR reference
21 CFR 876
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2014-07-25
Effective date
2014-07-25
HHS docket
Docket No. FDA-2012-N-0303
Abstract
The Food and Drug Administration (FDA) is issuing a final order to reclassify implanted blood access devices, a preamendments class III device, into class II (special controls) based on new information and subject to premarket notification and to further clarify the identification.