Newsletter | October 24, 2023

10.24.23 -- FDA's Proposed Laboratory-Developed Tests Rule Raises Many Questions But Provides Few Answers

FEATURED EDITORIAL

FDA’s Proposed Laboratory-Developed Tests Rule Raises Many Questions But Provides Few Answers

The FDA has issued a new proposed rule on laboratory-developed tests (LDTs), expressly defining LDTs as a type of in vitro diagnostic (IVD) device, and subject to device regulations, including registration and listing, premarket review, and more. The FDA is accepting comments on the proposed rule through December 4.

Risk Tool Selection With ICH Q9(R1) In Mind

This article focuses on the formality concept discussed in the revision of ICH Q9 Quality Risk Management released earlier in 2023. The authors provide a helpful overview of what risk tools are appropriate to use during certain types of scenarios, and what the team composition should look like.

INDUSTRY INSIGHTS

Increasing Delivery System Flexibility Through Solvent-Based Processing

Learn how a biodegradable polymer platform that is compatible with many substrates can enable several applications as a drug eluting carrier with a wide variety of APIs.

Proper Biological Indicator Placement During Vaporized Hydrogen Peroxide Decontamination Cycles

We discuss the three general BI types used for monitoring the VH2O2 cycles and directions on their proper placement in the isolator.

The Nuts And Bolts Of Brushless DC Motors

An overview of BLDC motors, their basic components, how they operate, how they differ, and where they are used.

High-Volume Manufacturing: Essential Points To Consider Before You Scale Up

To successfully scale to high-volume manufacturing, planning is required for streamlining the production process and minimizing the changes that could add unnecessary time and expense to the process.

Specialty LCP Compounds For Electronics Integration

In this article, Young Kim, Ph.D., senior principal engineer/chemist, Don DeMello, principal engineer field development, and Philip Wilson, Ph.D., marketing director medical, all of Celanese, discuss the benefits of recent advances in liquid crystal polymer for connected medical devices.

Thin-Wall Polyester Heat Shrink Tubing In Medical Device Manufacturing

Nordson MEDICAL has developed a proprietary process to manufacture thin-wall heat shrink tubing from Polyester (specifically, polyethylene terephthalate, or PET) that exhibits extraordinary tensile strength, even with walls as thin as 0.00015”.

RFID Disentangles Cryopreservation Storage And Management

Cryogatt Systems and HID Global developed a robust RFID tagging system to accurately identify and audit cryogenically stored items, overcoming challenges posed by extreme cold temperatures and frosting.

ARTICLES YOU MAY HAVE MISSED

Emerging Trends In Infusion/IV Therapy

Optimizing Combination Product Compliance: Integrated Development Solutions

A Brief Guide To ISO 13485’s Design Controls In Medical Device Development

Biosensing Technology: Where Is The Field Headed?

Global Market Trends For Drug-Device Combination Products

RESOURCES

Medical-Grade Capacitors: MD Series

XP Series Disc Pump

Uni-Patch S-Series (Classic) Stimulating Electrodes

Clamps And Clips

Connect With Med Device Online: