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Guidance Issuing OfficeCenter for Devices and Radiological Health
FDA has developed this draft guidance to propose select updates to the FDA guidance document "Guidance for the Non‐Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH)." The existing guidance on devices used for the treatment of BPH remains in effect, in its current form, until this draft guidance is finalized. FDA intends to incorporate this draft guidance into one final guidance document after obtaining and considering public comment on these select updates. The proposed sections referenced below are intended to replace applicable sections of the existing BPH guidance after FDA considers public comment on this draft guidance. The sections of the existing BPH guidance that are not affected by this select update will not be substantively changed and will remain in effect.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2020-D-1118.