Medical Devices; General and Plastic Surgery Devices; Classification of the Nonabsorbable Expandable Hemostatic Sponge for Temporary Internal Use
fda-device · Food and Drug Administration · Rule · Published 2014-06-16 · Effective 2014-07-16 · 79 FR 34222
Document
Document number
2014-13905
Federal Register citation
79 FR 34222
CFR reference
21 CFR 878
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2014-06-16
Effective date
2014-07-16
HHS docket
Docket No. FDA-2014-N-0655
Abstract
The Food and Drug Administration (FDA) is classifying the nonabsorbable expandable hemostatic sponge for temporary internal use into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the nonabsorbable expandable hemostatic sponge for temporary internal use classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.