Premarket Guidance Issued For Intravascular Administration Sets
This article was originally published in The Gray Sheet
Executive Summary
CDRH's guidance on 510(k)s for intravascular administration sets includes a section on microbial ingress testing - a topic CDRH officials have highlighted as an area in need of clarification
You may also be interested in...
CDRH General Hospital Devices Branch Takes On Software Applications
Increased submissions for medically-related software products are prompting CDRH's General Hospital Devices Branch to establish a premarket regulatory framework for the devices
Japan Regulatory Update: Revised Law Widens RWD Scope, Price Revisions/Listings
Japan now allows pseudonymized personal data for medical use under a licensing system for wider use of real-world data. Meanwhile, a national cost-effectiveness assessment scheme has slashed reimbursement prices for Lagevrio and Kerendia, and Alexion’s Voydeya has been added to the reimbursement tariff.
Abbott's ‘Bedrock Of Good Health’ Nutritionals Business Faces Mounting Infant Formula Litigation
Nutritional product business had 5.1% Q1 sales growth and is like Abbott’s other segments, “super well-aligned to the global demographics and trends in health care,” says CEO Ford. But as it defends complaints of damages from powder formulas made at facility found with unsafe levels of bacterial contaminants, Abbott’s also targeted in litigation alleging failure to warn about risk of infants born prematurely developing necrotizing enterocolitis if fed cow’s milk-based formula.