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FDA Issues Updated Final Guidance on Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH)
Today, the U.S. Food and Drug Administration (FDA) issued an updated final guidance: Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH). This guidance was previously issued as a final guidance in 2010.
This update includes several non-clinical and clinical testing recommendations and other minor changes to better align with the FDA's current thinking on these topics and to incorporate study design best practices.
Additionally, the updated final guidance adds several BPH treatment devices to the scope of the 2010 final guidance of the same name.
Facts about the updated final guidance
This guidance includes updated recommendations for the primary effectiveness endpoint for pivotal clinical studies of devices used for the treatment of BPH, as well as other clinical, preclinical, and nonclinical testing recommendations.
This guidance was updated to include the following types of devices potentially used by clinicians for the treatment of BPH:
- Embolic Agents
- Fluid Jet Removal Systems
- Implantable Transprostatic Tissue Retractor Systems
- An Additional Type of Endoscopic Electrosurgical Unit
- Temporarily Placed Urethral Opening Systems
Questions?
If you have questions about this final guidance, contact the Division of Industry and Consumer Education.
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