Dental amalgams
This article was originally published in The Gray Sheet
Executive Summary
FDA is in the process of reviewing over 750 comments relating to the proposed reclassification of dental amalgams, CDRH Director David Feigal testifies during Nov. 14 hearing before the House Government Reform Committee. Earlier this year, FDA reopened the comment period for a Feb. 20 proposed rule that would classify encapsulated amalgam and dental mercury as Class II (1"The Gray Sheet" July 22, 2002, p. 10). FDA, NIH and CDC plan further review of 1993 findings showing no definitive evidence linking the placement of amalgams to onset of systematic disease, according to Feigal...
You may also be interested in...
Regulatory News In Brief
Sleep apnea monitors: Effective Oct. 15, 1sleep apnea monitor final rule creates a separate category for the devices, which are currently classified as frequency breathing monitors. Manufacturers seeking clearance for sleep apnea monitors should demonstrate conformance to the sleep apnea monitor special controls guidance accompanying the July 17 final rule, or prove that the firm has taken equivalent measures to provide reasonable assurance of safety and effectiveness, FDA notes...
California Court’s Inaction On TiO2 Prop 65 First Amendment Case Breeds New Lawsuits
The Personal Care Products Council seeks to stem the rising tide of titanium dioxide Proposition 65 lawsuits, requesting that a California court prohibit the state’s Attorney General and private enforcers from filing and/or prosecuting new suits against cosmetics companies failing to warn about potential TiO2 exposure.
Kenvue Breaks Ground On New Headquarters, Appoints Chief Corporate Affairs Officer
Firm hosts groundbreaking for 290,000 square-foot global headquarters it’s having built in Summit, NJ, starting with 100,000 square-foot science and innovation and expected to open in 2025. It announced adding Russell Dyer as chief corporate affairs officer starting 13 March.