Promoting Your 510(k)-Pending Device: 5 Questions About FDA’s Policy

For almost 40 years FDA has allowed device firms to promote their device while a 510(k) submission is still pending.  Yet, questions about how to apply this policy still remain.  In an article newly published in MedTech Insight, titled "Promoting Your 510(k)-Pending Device: 5 Questions About FDA's Policy," Hyman, Phelps & McNamara, P.C.'s Jeffrey K. Shapiro answers some of the most frequently asked questions.