Medical Devices; Medical Device Reporting Regulations; Technical Amendment
fda-device · Food and Drug Administration · Rule · Published 2001-05-08 · Effective 2001-05-08 · 66 FR 23155
Document
Document number
01-11449
Federal Register citation
66 FR 23155
CFR reference
21 CFR 803
Type
Rule
Action
Final rule; technical amendment.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2001-05-08
Effective date
2001-05-08
HHS docket
Docket No. 98N-0170
Abstract
The Food and Drug Administration (FDA) is amending its regulations governing Medical Device Reporting (MDR) requirements. When the final regulation was last amended, the regulation published with some errors and omissions that, if uncorrected, may prove to be misleading. This document corrects those errors.