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USFDA Guidance: General Considerations for Animal Studies Intended to Evaluate Medical Devices

Today (27 March 2023) USFDA's Center for Devices and Radiological Health released final guidance on "General Considerations for Animal Studies Intended to Evaluate Medical Devices".


In this guidance document, the FDA provides recommendations for animal studies intended to evaluate medical devices intended for human use when no suitable alternative is available.

This advice primarily pertains to animal studies used in premarket submissions to the FDA to evaluate the safety of devices, including performance and handling.

One of the main goals of animal research submitted in support of a premarket submission is for the submitter to offer proof of a medical device's safety, which might include handling and performance.


A variety of elements of animal studies are recommended in this guidance, including the credentials of personnel conducting animal studies, as well as the planning and conduct of the study, including selecting an appropriate animal model, observing the study, and evaluating the study.


The guidance also includes recommendations on the choice of a testing facility, animal housing, records, and reports, as well as how to prepare an FDA premarket animal study report. These recommendations are based on current review practices and are intended to encourage consistency and streamline the process of reviewing medical device applications.


The Good Laboratory Practice for Nonclinical Laboratory Studies (GLP) Rules must be followed for all nonclinical laboratory research, including animal studies that support premarket submissions.


Also check out another final guidance that was finalized and released today, "Soft (Hydrophilic) Daily Wear Contact Lenses - Performance Criteria for Safety and Performance Based Pathway" which provides the FDA's recommendations on performance criteria to support premarket submissions for soft (hydrophilic) daily wear contact lenses in the Safety and Performance Based Pathway.

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