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Posted: April 3, 2017

Extractable/Leachable Chemistry Testing Strategies for Medical Devices

By Matthew R Jorgensen, Ph.D., and Thor Rollins, BS, Nelson Laboratories; Allison Komiyama, Ph.D., RAC, AcKnowledge RS
Published: Medical Device Outsourcing 

It has become more prevalent and acceptable to use the results of chemistry testing to assess the overall biocompatibility of medical devices. For many devices with prolonged or permanent patient contact, chemistry followed by toxicological assessment can provide a cost and time saving alternative to in vivo tests such as chronic, sub-chronic, genetic, and carcinogenicity testing. Manufacturers preparing to submit their device for approval by the U.S. Food and Drug Administration (FDA) rely on ISO 10993 standards and FDA guidance on the application of those standards in the planning of their chemistry testing. When it comes to the details of chemistry testing, however, the ISO standards are often vague. Furthermore, the recommendations regarding the appropriate level of testing rigor can vary within FDA. The following offers a brief overview of the framework provided by ISO 10993 guidance documents for extractable/leachable (E/L) testing, as well as three testing strategies that satisfy both ISO 10993 and FDA requirements.

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ARTICLE

Posted: January 17, 2017

A "Particle" of Prevention Is Worth a Pound of Cure: The Significant Benefits of Premarket & Postmarket Particulate Testing of Cardiovascular Devices

The Significant Benefits of Premarket & Postmarket Particulate Testing of Cardiovascular Devices

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ARTICLE

Posted: December 21, 2016

How Chemical Characterization Can Supplement and Support Biocompatibility Testing

By Sarah Campbell, PhD; Thor Rollins; Audrey Turley

Using analytical chemistry and data from the compound libraries to assess the finished device can yield more specific data about these extractable compounds than biocompatibility testing. The known properties of the compounds can then be used to create a toxicological risk or safety assessment based on the predicted biological response to the compounds. Download the whitepaper to learn more.

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ARTICLE

Posted: November 22, 2016

New FDA Guidance for 510(k) Submission of Orthopedic Medical Implants

By Martell Winters, Senior Scientist and Consulting Manager; Quinton Inglet, Section Leader, Bacterial Endotoxin Testing
Published: Orthopedic Technology & Design

The document could have a significant impact on the testing regimen for implant device manufacturers. The U.S. Food and Drug Administration (FDA) released a new guidance document titled “Submission and Review of Sterility Information in Premarket Notification [510(k)] Submissions for Devices Labeled as Sterile” on Jan. 21, 2016, which underwent some small editorial changes and was updated in March. This document has resulted in far-reaching changes to the 510(k) submission process for implant manufacturers. Of note, it specified new requirements related to bacterial endotoxin testing (BET).

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ARTICLE

Posted: October 3, 2016

Top 3 Questions About Extractable/Leachable Testing

By Matthew R. Jorgensen, PhD
Published: MD+DI online

Extractable/leachable chemistry testing can save, time, money, and animal life for certain classes of devices. Over the past decade, regulatory bodies have shifted their evaluation of biocompatibility from a strict linear approach to a less linear approach that includes in vitro tests and assessment using chemistry. Chemistry has the advantage of providing detailed information on the identity and amount of substances that can leave devices, while traditional biocompatibility tests are pass or fail. The challenge with chemistry can be that a deeper understanding of device materials and the science of extractable/leachable testing is required to correctly interpret results. Fortunately, for those companies without expertise in using chemistry to fulfill regulatory requirements, help is available through consulting services. The following are three frequently asked questions when consulting on these matters.

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