Medical Device; Exemption From Premarket Notification; Class II Devices; Pharmacy Compounding Systems
fda-device · Food and Drug Administration · Rule · Published 2001-03-21 · Effective 2001-03-21 · 66 FR 15796
Document
Document number
01-6938
Federal Register citation
66 FR 15796
CFR reference
21 CFR 880
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2001-03-21
Effective date
2001-03-21
HHS docket
Docket No. 00P-1554
Abstract
The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for pharmacy compounding systems classified within the intravascular administration set, with certain limitations. This rule will exempt from premarket notification pharmacy compounding systems classified within the intravascular administration set and establishes a guidance document as a special control for this device. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA).