On Monday, the FDA released draft guidance for the design of studies supporting premarket and 510(k) submissions. The document lays out the foundational features of medical device trials, including guidance on the types of studies, as well as how to avoid bias and establish controls in the study. The document frames its recommendations in two broad categories “therapeutic and aesthetic devices” and “diagnostic devices.”
"This guidance will help manufacturers and researchers better understand the FDA's basic expectations for clinical trials," Dr. Jeffrey Shuren, director of the FDA's Center for Devices & Radiological Health, said in the FDA’s press release.
The FDA stated in its press release that the guidance document was designed primarily for devices undergoing premarket approval submissions, but that the document's guidance recommendations may also apply to 510(k) applications. The FDA will accept public comments on the draft guidance until November 15, 2011.
Click here to read coverage of the announcement in Mass Device.
Click here to read the FDA’s press release announcing the Draft Guidance.
Click here to view the Draft Guidance Document.