FDA Focuses On Animal Testing, Trial Endpoints In BPH Device Draft Guidance
Draft guidance from the US FDA updates the agency’s recommendations around research to support new devices for the treatment of prostate enlargement.
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A new guidance document from the US agency strongly urges makers of medical devices for treating benign prostatic hyperplasia (BPH) – a common form of age-related prostate enlargement – to quickly conduct post-treatment evaluations as part of investigational studies.
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The guidance document explains the history of and requirements for electronic submissions of 510(k)s.