Newsletter | February 11, 2021

02.11.21 -- With Release Of New Guidance Document, FDA Launches Safer Technologies Program for Medical Devices
 
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Featured Editorial
With Release Of New Guidance Document, FDA Launches Safer Technologies Program for Medical Devices
 
By Mark Durivage, Quality Systems Compliance LLC

The FDA’s Center for Devices and Radiological Health (CDRH) released the Safer Technologies Program for Medical Devices (STeP) Guidance for Industry and Food and Drug Administration Staff on January 6, 2021, with plans to begin accepting applications for STeP beginning March 8, 2021. Is this a good fit for your medical device or device-led combination product?
Avoiding ISO 14971 Mistakes — What Does “Harm” Really Mean?
 
By Naveen Agarwal, Ph.D., Creative Analytics Solutions, LLC

In the first two parts of this three-part series on ISO 14971 terminology, we discussed the terms “hazard” and “hazardous situation” in detail. In this third and final part, we will review the term “harm,” provide examples to illustrate how you can define potential harms applicable to your medical device, and explain how you can link them to relevant hazards and hazardous situations. 
Industry Insights
The Market For 3D Printed Bioresorbable CMF Plates And Other Complex Devices Is Being Redefined By New GMP-Grade Filament Material
Article | By Balaji Prabhu, Evonik Corporation

The adoption of 3D printing technologies for implantable medical devices has been relatively slow and largely confined to metal-based implants traditionally used for hip, knee, and spine reconstruction applications. This has been due to challenges in sourcing the right biocompatible materials, validating processes, and adhering to quality and regulatory requirements.
UV Sterilization: Eliminating Bacteria Using Advanced LED Technology
Article | By Dr. Frank Gindele, SCHOTT North America Inc.

UV radiation is the only sterilant that directly destroys the DNA of bacteria and other contaminants. Hermetically sealed LEDs provide a viable alternative to conventional UV technologies.
The Benefits Of Aqueous Critical Cleaning In Pharmaceutical Manufacturing
Article | By Malcolm McLaughlin and Jeff Phillips, Alconox, Inc.

The use of aqueous cleaning in pharmaceutical manufacturing can provide numerous benefits in terms of efficacy, minimal surface contact, reduced residue potential, and easier cleaning validation.
The Only Validation Approach That Gets — And Keeps — Your Molded Part In Spec
White Paper | By Bob Emmett and Luke Lorson, Carclo Technical Plastics

When subcontracting medical or optic injection molded components, do you carefully evaluate your molder’s validation process? There is only one approach that is proven to keep your molded parts “in spec”: decoupled molding.
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Resources
Bioceramics And Composites Presentation
DSM Biomedical
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Direct Metal Laser Sintering Capabilities
Protolabs, Inc.