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FDA

October 12, 2016

Reprocessing Single-Use Devices

Some devices that are marketed and validated for single use are now being used multiple times in clinical settings. To save money and to comply with green initiatives, hospitals are moving towards using third-party reprocessed single-use devices (SUDs). However, reusing...

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July 29, 2016

Human Factor Considerations for Medical Device Manufacturers

Consideration of human factors when designing a medical device should be a high priority. It is important that concerns regarding human factors are considered during the development phase of new medical devices. For many years, this phase of the process...

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July 6, 2016

New US FDA Guidance on the Use of International Standard ISO 10993-1: Top 10 Changes

As anticipated, the United States Food and Drug Administration (US FDA) issued a new guidance document on the use of ISO 10993-1 on June 16, 2016. In one statement the FDA summarizes how they want to see biocompatibility for medical...

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July 1, 2016

Dr. Victoria Hitchins Remembered at Nelson Laboratories

Victoria Hitchins, PhD, of the FDA passed away on Friday, June 17, 2016.  Dr. Hitchins was a respected microbiologist who made many contributions to the public health industry.  Emily Mitzel, Technical Consulting Manager at Nelson Labs, worked with Dr. Hitchins...

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June 16, 2016

FDA Releases ISO 10993-1 Guidance Document

FDA released the long-awaited guidance document for international standard ISO 10993-1 this week. The guidance document represents the current thinking of FDA on the topic of ISO 10993-1 “Biological evaluation of medical devices – Part I: Evaluation and testing within...

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