Articles and Blogs

On January 20, 2015, the Food and Drug Administration (the “FDA” or “Agency”) published two draft guidance documents designed to fulfill promises it made in the multi-agency Food and Drug Administration Safety and Innovation Act (“FDASIA”) Health IT report. The first draft guidance is intended to promote the innovation of general wellness devices and... READ MORE

In November 2014, the ECRI Institute¹ issued a report discussing issues of patient safety and adverse events linked to health information technology (“IT”) products. The report comes in the form of an annual list of top ten health technology safety hazards. According to the ECRI Institute, although many facets of health IT have a... READ MORE

This article has been republished with permission from the American Health Law Association. On December 31, the Food and Drug Administration (FDA) issued a guidance stating that it will delay enforcement of certain new product tracing requirements, included in the recently enacted Drug Supply Chain Security Act (DSCSA), until May 1. The delayed requirements... READ MORE

According to a Federal Register notice published on May 5, physicians and teaching hospitals will soon be able to register with the Centers for Medicare and Medicaid Services (“CMS”) to receive notices from and access to CMS’s Open Payments database.  The Open Payments database will contain information about payments and other transfers of value that... READ MORE

Executive Summary Recently, legislation was introduced in Congress that seeks to combat the growing problem of prescription drug abuse.  United States Representative Gus Bilirakis (R-FL), along with his co-sponsor Representative Ben Lujan (D-NM), introduced H.R. 3392, the Medicare Part D Patient Safety and Drug Abuse Prevention Act of 2013, in a bipartisan effort to... READ MORE

The U.S. Food and Drug Administration (“FDA”) has issued draft guidance on its Investigational Device Exemption (“IDE”) process for medical devices, titled Decisions for Investigational Device Exemption Clinical Investigations.  The draft guidance introduces a new pre-decisional IDE review process, through which medical device sponsors can seek the FDA’s input on significant issues before submitting... READ MORE

The U.S. Food and Drug Administration (“FDA”) wants to give manufacturers of medical devices in vitro diagnostics (“IVDs”) and biological products the authority to use certain symbols and images on their product labeling to convey safety information and instructions for use. A proposed rule published April 19 would revise the agency’s regulations at 21... READ MORE

This article is Part II in a five-part series of articles discussing the recently published federal Physician Payment Sunshine Act (“Sunshine Act”).  This article focuses on issues specific to group purchasing organizations and physician investment in health product manufacturers.  The first article in the series provided an overview of the major sections of the... READ MORE

This article is Part I in a five-part series discussing the federal Physician Payment Sunshine Act.  This first installment provides an overview of the major sections of the Sunshine Act and CMS’s implementing rule, with a focus on issues of importance to health product manufacturers and entities sharing an ownership structure with manufacturers.  Part... READ MORE