Food and Drug Administration

CABI Office of the Federal Register / National Archives and Records Administration · Rulemaking audits

Micro-Tracers, Inc.; Response to Objections and Requests for a Public Hearing

Health and Human Services Department, Food and Drug Administration | Rule | The Food and Drug Administration (FDA or we) received objections and requests for a public hearing submitted by Buchanan Ingersoll & Rooney PC, on behalf of Micro-Tracers, Inc. (Micro-Tracers or objector), on the order granting a color additive petition (3C0323) requesting that we repeal specified regulations to no longer provide for the safe use of FD&C Red No. 3 in food (including dietary supplements) and ingested drugs. After reviewing the objections, we have concluded that the objections do not raise issues of material fact that justify a hearing. We are also providing notice that the administrative stay of the..

CW Claire Walsh

Aug 5 · 1 min

CABI Office of the Federal Register / National Archives and Records Administration · Rulemaking audits

Medical Devices; Orthopedic Devices; Classification of the Medial Knee Implanted Shock Absorber

Health and Human Services Department, Food and Drug Administration | Rule | The Food and Drug Administration (FDA) is classifying the medial knee implanted shock absorber into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the medial knee implanted shock absorber. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

CW Claire Walsh

Jun 29 · 1 min