Medical Devices; Exemption From Premarket Notification; Class II Devices; Optical Impression Systems for Computer Assisted Design and Manufacturing
fda-device · Food and Drug Administration · Rule · Published 2003-04-22 · Effective 2003-04-22 · 68 FR 19736
Document
Document number
03-9869
Federal Register citation
68 FR 19736
CFR reference
21 CFR 872
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2003-04-22
Effective date
2003-04-22
HHS docket
Docket No. 02P-0494
Abstract
The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for data acquisition units for ceramic dental restoration systems. This rule exempts from premarket notification data acquisition units for ceramic dental restoration systems 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).