On October 14, the FDA issued a draft guidance document to assist industry in designing evaluation strategies for, and reporting the results of, animal studies for medical devices. The studies utilized for the assessment of these devices typically provide initial evidence of device safety, their potential performance when used in a living system, and the biologic response that a living system may mount towards the device.

This guidance provides recommendations for members of industry who perform, and FDA staff who review evaluations of, animal studies for medical devices. Companies may submit comments and suggestions regarding this draft document within 90 days of in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to www.regulations.gov .

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