Illness Risk Fuels FDA Ban On Powdered Surgical Gloves
This article was originally published in The Gray Sheet
Executive Summary
An FDA determination of substantial risk of illness and injury from use of absorbable powdered surgical gloves has sparked a proposed product ban by the agency.
You may also be interested in...
Powdered Gloves No More: FDA Finalizes Ban
US FDA has banned sales of powdered gloves, its first outright device category ban in more than 30 years.
FDA Chief Counsel Addresses Staff Turnover, Device Bans
Staff turnover in FDA's Office of the Chief Counsel is a positive, says the agency's top lawyer Elizabeth Dickinson. The chief counsel also discussed recent device bans, off-label communication policy efforts and the agency’s ongoing transparency initiative at the annual Food & Drug Law Institute conference.
CDRH Sets Performance Goals To Reduce Draft Guidance Ambiguity
The device center has committed to metrics for draft guidance documents, trying to address complaints that policies linger too long in the draft stage and create regulatory confusion. CDRH also highlighted recent website upgrades intended to better distinguish between draft and final guidance documents.