Medical Devices; Exemption From Premarket Notification; Class II Devices; Triiodothyronine Test System
fda-device · Food and Drug Administration · Rule · Published 2000-10-18 · Effective 2000-10-18 · 65 FR 62285
Document
Document number
00-26740
Federal Register citation
65 FR 62285
CFR reference
21 CFR 862
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2000-10-18
Effective date
2000-10-18
HHS docket
Docket No. 00P-1280
Abstract
The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for the triiodothyronine test system with certain limitations. This rule will exempt from premarket notification the triiodothyronine test system intended for measuring the hormone triiodothyronine in serum and plasma. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Action of 1997 (FDAMA).