Hyman Phelps and McNamara
Firm Publications

Promoting Your 510(k) - Pending Device: 5 Questions About FDA's Policy
October 12, 2016

A 510(k) submission rather than a 510(k) clearance is the threshold that a device firm needs to meet to being advertising or displaying a product under a long-established, one-sentence agency policy. But important questions remain about proper application of this policy by the Industry. This article will answer those questions.

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If you have any questions regarding the above information, please contact:
Jeffrey K. Shapiro (202) 737-9633 jshapiro@hpm.com