Guest Columns
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FDA Finalizes Guidance About Delaying, Denying, Limiting, Or Refusing An Inspection
7/25/2024
The FDA has finalized a guidance on the circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. The agency also provides reasons that may cause drugs or devices to be adulterated under the FD&C Act.
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Is Your Lab Ready For A LIMS Implementation?
7/25/2024
Deploying a laboratory information management system (LIMS) can boost your quality control lab's productivity, but how are you going about it? This article shares key steps and considerations for setting up your physical lab, controlling inventory, and more.
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Bacterial Endotoxin Testing, Part 2: Prerequisites & Reagent Preparation
7/23/2024
In this second article of a planned series about bacterial endotoxin testing, the author shares best practices about prerequisites and reagent preparation for a gel clot Limulus amebocyte lysate (LAL) test.
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How Early Talks With The FDA Can Pave Your DTx Approval Pathway
7/22/2024
Consultant Acacia Parks discusses when and how DTx developers should work with the FDA to improve their overall development and clinical trial processes.
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Making Good Decisions When FDA Investigators Come Knocking
7/18/2024
Ready or not, when the FDA inspector arrives, the test has already started. New final guidance makes clear what the agency considers an attempt to stonewall.
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Answer These Questions To Guide Your Prototyping Strategy
7/18/2024
This article shares key questions for your team to ask yourselves about demonstrating proof-of-concept with a functional prototype of your medical device.
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5 Recommendations To Maximize CSV/CSA Outcomes
7/17/2024
The computer system validation (CSV)/computer system assurance (CSA) process is correlated with other departments besides IT and quality. Accordingly, all stakeholders must think ahead and define what they need.
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Bacterial Endotoxin Testing, Part 1: Overview
7/16/2024
All injectable drug products and implantable medical devices that come into contact with the bloodstream or spinal fluid are tested for endotoxins. This article provides an overview of bacterial endotoxin testing and the LAL method.
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Data-Driven Trends In Predetermined Change Control Plans
7/12/2024
The FDA introduced the concept of the predetermined change control plan to address the dynamic nature of medical devices, particularly those using software and AI. Bridging Consulting conducted a data-driven study and shares the key findings.
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Understanding The Potential Of AI Med Devices Amid Regulatory Challenges
7/9/2024
As AI medical devices continue to evolve, collaborating with regulatory experts and embracing multidisciplinary approaches are crucial for navigating challenges and ensuring regulatory compliance.