This guidance identifies the key features of non‐clinical and clinical investigational plans used to support investigational device exemptions (IDEs), premarket approval applications (PMAs), and some premarket notifications (510(k)s) for devices used in the treatment of BPH. Some recommendations in this document may not apply to a particular device, and additional recommendations may be appropriate for novel device types or technologies. FDA will consider alternative non‐clinical and clinical testing when the proposed alternatives are supported by an adequate scientific rationale. We encourage you to contact the Urology and Lithotripsy Devices Branch (ULDB) when designing your clinical investigation and prior to submission of an original IDE application.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.