https://www.fda.gov/regulatory-information/search-fda-guidance-documents/select-updates-guidance-non-clinical-and-clinical-investigation-devices-used-treatment-benign?utm_campaign=2020-07-13%20Draft%20Guidance%20BPH%20Device%20Update&utm_medium=email&utm_source=Eloqua

FDA Issues Draft Guidance for Select Updates to 2010 BPH Device Final Guidance

Today, the U.S. Food and Drug Administration (FDA) issued a draft guidance: Selected Updates for Guidance for the Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH). The draft guidance proposes the addition of several BPH treatment devices to the 2010 final guidance of the same name. Additionally, this draft guidance updates several non-clinical and clinical testing recommendations to better align with the FDA’s current thinking on these topics and to incorporate study design best practices.

Read the Guidance Facts about the draft guidance Devices proposed to now fall under the scope of the final guidance include  Embolic Agents Fluid Jet Removal Systems Implantable Transprostatic Tissue Retractor Systems An Additional Type of Endoscopic Electrosurgical Units Questions? If you have questions about this final guidance, contact the Division of Industry and Consumer Education.