Medical Devices; Medical Device Reporting; Baseline Reports; Stay of Effective Date
fda-device · Food and Drug Administration · Rule · Published 1996-07-31 · Effective 1996-07-31 · 61 FR 39868
Document
Document number
96-19411
Federal Register citation
61 FR 39868
CFR reference
21 CFR 803
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
1996-07-31
Effective date
1996-07-31
Abstract
In response to numerous requests for the Food and Drug Administration (FDA) to further consider comments concerning manufacturer medical device reporting (MDR) baseline reporting requirements, FDA is staying the effective date of certain portions of the baseline reporting requirements. The stay of these requirements will allow FDA to further evaluate the issues raised by the comments and to determine whether the requirements should be revised.