Medical Devices; Retention of Three Preamendment Class III Devices in Class III
fda-device · Food and Drug Administration · Rule · Published 1998-06-30 · 63 FR 35516
Document
Document number
98-17290
Federal Register citation
63 FR 35516
CFR reference
21 CFR 868
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
1998-06-30
HHS docket
Docket No. 94N-0418
Abstract
The Food and Drug Administration (FDA) is retaining the following three preamendments class III devices in class III: Lung water monitor, powered vaginal muscle stimulator for therapeutic use, and stair-climbing wheelchair. The agency is taking this action because insufficient information exists to determine that special controls would provide reasonable assurance of their safety and effectiveness, and/or these devices present a potential unreasonable risk of illness or injury.