Oct 29, 2017

How close to the marketed product should test articles be for medical device or combination product GLP preclinical testing?

Medical Device and combination product test articles for 21 CFR Part 58 GLP preclinical testing should be representative of what is intended for use in clinical trials (design freeze).

Making changes to an article after preclinical testing may necessitate additional bench-top testing and/or preclinical studies

• Making changes to an article after preclinical testing may necessitate additional bench-top testing and/or preclinical studies
• Handling, storage, and use should mimic conditions intended for humans
• It is not recommended that expired product or product rejected for specification failure be used in a GLP study - for either test or control article - as it may bring into question whether it truly mimics the clinical device (test article) or provides an appropriate comparison (control article)

When planning an FDA GLP preclinical study for a medical device or combination product, it is important to consider the strategy for dealing with test and control article requirements early in the process, to ensure appropriate documentation of article build, packaging, sterilization, and testing, as well as retention of appropriate reserve samples. As your trusted preclinical partner, Surpass is here to help you through the entire GLP process. We will be posting additional entries in our blog with useful information for planning a GLP Study, so stay tuned. 

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