Medical Device; Exemption From Premarket Notification; Class II Devices; Barium Enema Retention Catheters and Tips With or Without a Bag
fda-device · Food and Drug Administration · Rule · Published 2000-12-08 · Effective 2000-12-08 · 65 FR 76930
Document
Document number
00-31292
Federal Register citation
65 FR 76930
CFR reference
21 CFR 876
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2000-12-08
Effective date
2000-12-08
HHS docket
Docket No. 00P-1343
Abstract
The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for barium enema retention catheters and tips with or without a bag with certain limitations. This rule will exempt from premarket notification barium enema retention catheters and tips with or without a bag. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).