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Guidance Documents/Guidance-Document/Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH): Guidance for Industry and Food and Drug Administration Staff

Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH): Guidance for Industry and Food and Drug Administration Staff

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

December 27, 2021

December 23, 2021

Center for Devices and Radiological Health

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