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Guidance Issuing OfficeOffice of Medical Products and Tobacco, Center for Devices and Radiological Health
This guidance addresses the use of a randomized clinical trial (RCT) approach in designing clinical studies for catheter ablation devices for the treatment of atrial flutter. The first several premarket approval (PMA) applications approved for the treatment of atrial flutter relied on clinical data from single-arm trials because no devices were approved for treatment of atrial flutter. Recently approved IDE studies and PMA applications have used the option of a RCT given the availability of PMA-approved ablation catheters indicated for treatment of atrial flutter. This guidance provides recommendations about the clinical study designs that rely on a RCT.
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-0957.