Life Science Compliance Update, June 2015: Important Sunshine Considerations for Medical Device Manufacturers, DOJ Enforcement Priorities, the Importance of the “Front End” of Transparency

The June 2015 issue of Life Science Compliance Update, available with a subscription here, offers a compliance update for medical device manufacturers.

Issue Summary

In this month’s issue, you’ll find a thorough look at enforcement activity against device companies, as well as insight into enforcement issues on the horizon. This issue also features an article on best practices for aggregate spend compliance entitled “The Importance of the Front End of Transparency,” by David Davidovic, Founder, pathForward and Senior Advisor, Polaris Management; Former VP, Commercial Services, Genentech and Roche.

Further, Abraham Gitterman, JD, a healthcare associate at Arnold & Porter, provides insight into five Sunshine Act issues that device manufacturers must play close attention to, a timely subject with the second year of Open Payments data set to be published at the end of June. Finally this issue offers a concise overview of where the FDA stands in its decision to regulate laboratory developed tests as medical devices. 

Table of Contents

Five Sunshine Act Considerations for Medical Device Manufacturers, by Abraham Gitterman, JD, FDA/Healthcare Associate, Arnold & Porter and Matthew Chandler, JD, Senior Writer, Life Science Compliance Update

The Importance of the Front End of Transparency, by David Davidovic, Founder, pathForward and Senior Advisor, Polaris Management; Former VP, Commercial Services, Genentech and Roche

Quick Take: FDA’s Oversight of Laboratory Developed Tests

 Medical Device Enforcement Developments: 

• What are DOJ’s Frequent Targets?
• Case to Watch: U.S. v. Reliance Medical Systems

 Scrutiny Into Physician-Owned Distributorships

Subscription

An annual individual subscription of 12 electronic issues is available for $1,200.00 U.S, with multiple subscriber-based discounts available. To learn more and to purchase, visit www.lifescicompliance.com. A free sample issue also is available for download by visiting www.lifescicompliance.com.