Newsletter | April 4, 2024

04.04.24 -- Notable Public Comments On The FDA's Proposed Regulation For Laboratory Developed Tests

FEATURED EDITORIAL

Notable Public Comments On The FDA’s Proposed Regulation For Laboratory Developed Tests

The proposed FDA regulation for laboratory developed tests marks a significant step toward the FDA trying to standardize oversight for these diagnostic tools. As the FDA seeks public input, it is a hot topic as stakeholders grapple with the implications of increased regulatory scrutiny, debating its impact on patient access, innovation, and the overall landscape of diagnostic testing in the U.S.

INDUSTRY INSIGHTS

Back To Basics: Breaking Down The Fundamentals Of Filters

Regardless of the technology behind the filter, there are several key concepts that all filters share. Explore fundamental filter information that will help simplify future filtering decisions.

Optimizing Your Critical Cleaning Process To Ensure Results

Getting the best results from any cleaner requires proper mixing and cleaning procedures. This article includes mixing directions for aqueous cleaning detergent and methods for monitoring performance.

Best Practices For Connecting A Variable Volume Pump With A Fluidic System

Discover optimal fluid connection and mounting strategies for variable volume pumps, ensuring precise fluid control and system performance in your design process.

Manufacturing Transfers For Medtech OEMs: Part 1

Quality management is a mission-critical function of all MedTech manufacturers. Attention to quality issues when selecting vendors and partners can help manufacturers prevent downstream issues.

ARTICLES YOU MAY HAVE MISSED

Rapid Diagnostics And The Quest To Develop The Fabled Star Trek Tricorder

The Future Of Early Disease Detection: Breath-based Screening & Diagnostics

Getting Out Of The Doldrums: Analyzing & Kickstarting Organizational Quality Maturity

Using Relational Risk Analysis To Control Procedure Failures

A Successful Technology Strategy For Medical Device Teams Asking, “Own Or Partner?”

RESOURCES

Material Selection For Medical Device Manufacturability

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