Sterility symbol compromise
This article was originally published in Clinica
Executive Summary
The European standards committee, CEN, has approved a new symbol for indicating sterility of medical devices. This is effectively a compromise symbol aimed at manufacturers of products that cannot tolerate sterilisation to 10-(6), the level required to apply the symbol for absolute sterility. The new symbol, which will be introduced in a second amendment to the European standard on medical device labelling and symbols, EN 980, is for aseptic processing.
You may also be interested in...
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.
GLP-1 Coverage Restrictions In Medicare Part D Surge As Demand For Obesity Drugs Grows
A major shift from unfettered coverage to prior authorizations was recorded by MMIT over the past year for the leading GLP-1/GIP agonist diabetes drugs. Public interest in using the drugs off label for weight loss drove the change.