Medical Devices; Medical Device Reporting; Baseline Reports; Confirmation of Effective Date
fda-device · Food and Drug Administration · Rule · Published 2008-09-17 · Effective 2008-10-27 · 73 FR 53686
Document
Document number
E8-21756
Federal Register citation
73 FR 53686
CFR reference
21 CFR 803
Type
Rule
Action
Direct final rule; confirmation of effective date.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2008-09-17
Effective date
2008-10-27
HHS docket
Docket No. FDA-2008-N-0310
Abstract
The Food and Drug Administration (FDA) is confirming the effective date of October 27, 2008, for the final rule that appeared in the Federal Register of June 13, 2008 (73 FR 33692). The direct final rule amends the Medical Device Reporting regulation by removing the requirement for baseline reports. This document confirms the effective date of the direct final rule.