From the Editor — A Look Back, and Ahead

Beth G. Sisk, Editor

The end of the year is practically upon us so let’s take a quick look back at some of the highlights of 2013. On January 1, 2013, the 2.3% Medical Device Excise Tax, which manufacturers and importers pay on sales of certain medical devices, went into effect to help fund the Patient Protection and Affordable Care Act. By July 15, the Advanced Medical Technology Association (AdvaMed) announced that medical device manufacturers had already paid an estimated $1 billion to the Internal Revenue Service for the tax.

The Medical Category winners at the Create the Future De sign Contest Awards Dinner accept their plaque. (Left to Right: Dr. John Muth, James Dieffenderfer, Leigh Johnson, Mike Brown, and contest sponsor Bernt Nilsson from COMSOL)

The U.S. Food and Drug Administration issued a final rule for the unique device identification system (UDI), which requires that most medical devices distributed in the US carry a unique device identification number assigned by the device manufacturer, and includes production-specific information that will provide a consistent way to identify those devices. This will be phased in over the next few years. In addition, a draft guidance was issued regarding the establishment of a publicly searchable database administered by the FDA, called the Global Unique Device Identification Database (GUDID) that will serve as a reference catalogue for every device with a UDI.

The FDA also issued a final guidance document describing its policy on regulating mobile medical applications (apps). It clarifies that the FDA will focus on regulating only those apps that are used as accessories to already-regulated medical devices, and apps that transform a mobile platform into an already-regulated medical device.

Looking forward to 2014, the FDA plans to provide final guidance on such topics as cybersecurity in premarket submissions, human factors and usability engineering for device design, clarifications about the 510(k) program, and establishing the GUDID.

Here at Medical Design Briefs, we added new columns this year, including R&D Roundup, which covers current and ongoing research and innovations being conducted at leading universities, research centers, and hospitals. The Executive Outlook column, which appears six times yearly, targets industry topics of specific interest to medtech managers and executives. We added a Product of the Month to the listings of new products. See page 36 about how to vote for the Readers’ Choice Product of the Year award.

For 2014, we will be adding a new Leadership Series section that will cover Technology Leaders in Connectors/Wires/ Cables; Tubing/Extrusion; Outsourcing; Motors & Motion Control; Electronics; Gas/Fluid Handling/Drug Delivery; and Materials/Coatings/Adhesives.

Happy Holidays!