Newsletter | August 27, 2024

08.27.24 -- FDA Issues Draft Guidance On Use-Related Risk Analysis (URRA)

FEATURED EDITORIAL

FDA Issues Draft Guidance On Use-Related Risk Analysis (URRA)

The FDA released a new draft guidance, "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products," in July. The public comment period closes on Sept. 9, 2024.

Bacterial Endotoxin Testing, Part 2: Prerequisites & Reagent Preparation

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.

INDUSTRY INSIGHTS

RFID In Medical Devices: 4 Biggest Benefits For OEMs

Go in-depth on the challenges faced by medical device Original Equipment Manufacturers (OEMs) and how RFID technology can provide a comprehensive solution.

Material Selection For Medical Device Manufacturability

Choosing the right material in the earliest stages of research & development can make all the difference in beating your competitors to market and avoid increased project costs, development delays and manufacturing setbacks.

Media-Separated Solenoid Valves For Gene Sequencing & Synthesis

Advancements in gene sequencing technology and fluidic components like media-separated solenoid valves are revolutionizing genomic research and synthesis for disease diagnosis and treatment.

Selecting Capacitors For Life-Critical Applications

This white paper explores regulation, testing procedures, and supplier considerations to assist in choosing the best components for each medical application. 

Sustained-Release Implants: A Targeted Approach To Drug Delivery

Implantable drug delivery systems hold the potential to revolutionize cancer treatment by enhancing efficacy, reducing toxicity, and alleviating the burden of treatment for patients.

ARTICLES YOU MAY HAVE MISSED

Answer These Questions To Guide Your Prototyping Strategy

Understanding The Potential Of AI Med Devices Amid Regulatory Challenges

5 Recommendations To Maximize CSV/CSA Outcomes

Bacterial Endotoxin Testing, Part 1: Overview

Adaptive AI-Driven Medical Devices In The US: Regulatory Guidelines

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