Medical Devices; General and Plastic Surgery Devices; Classification of Non-Powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy
fda-device · Food and Drug Administration · Rule · Published 2010-11-17 · Effective 2010-12-17 · 75 FR 70112
Document
Document number
2010-28873
Federal Register citation
75 FR 70112
CFR reference
21 CFR 878
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2010-11-17
Effective date
2010-12-17
HHS docket
Docket No. FDA-2010-N-0513
Abstract
The Food and Drug Administration (FDA) is classifying the non- powered suction apparatus device intended for negative pressure wound therapy (NPWT) into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Non-Powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy." 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. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability for the guidance document entitled "Class II Special Controls Guidance Document: Non-Powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy."