Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
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...
You may also be interested in...
Dental amalgams
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...
Dental amalgams
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...
BIMO Routine Inspections Will Be Pre-Announced
CDRH's bioresearch monitoring division (BIMO) has started pre-announcing routine audits. Under the new policy, the inspections are being announced about five days beforehand