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GUIDANCE DOCUMENT

Select Updates for Guidance for the Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH) Draft Guidance for Industry and Food and Drug Administration Staff July 2020

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
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


Docket Number:
FDA-2020-D-1118
Issued by:
Guidance Issuing Office
Center 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FDA has developed this draft guidance to propose select updates to the FDA guidance document "Guidance for the Non‐Clinical and Clinical Investigation of Devices Used for the Treatment of Benign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 The existing guidance on devices used for the treatment of BPH remains in effect, in its current form, until this draft guidance is finalized. FDA intends to incorporate this draft guidance into one final guidance document after obtaining and considering public comment on these select updates.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are intended to replace applicable sections of the existing BPH guidance after FDA considers public comment on this draft guidance.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.

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