Liquid chemical sterilants/high level disinfectants
This article was originally published in The Gray Sheet
Executive Summary
Guidance issued Jan. 3 on submission of 510(k)s for germicides and other disinfectants requires applicants to perform testing to show compatibility with specific materials and devices. "FDA encourages the germicide 510(k) sponsor to work with reusable device manufacturers to evaluate the effect of repeated use of the germicide on device functionality," the guidance states. Document supersedes previous guidance on the subject issued in December 1997
You may also be interested in...
Pink Sheet Podcast: Leqembi Spending, Woodcock’s Next Act, Pneumococcal Vaccine Development
Pink Sheet editors discuss Medicare spending projections for the Alzheimer’s treatment Leqembi, Janet Woodcock’s new post-FDA role, and ongoing preparations for new pneumococcal vaccines that will reach the market soon.
Investors Go Berserk For Viking, Putting It Top Of Q1 Winners
The top 10 biggest share price winners and losers in Q1 from Evaluate show the investor frenzy for obesity drugs continues, while companies with governance doubts see shareholders retreat.
EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications
Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.