UDI Proposed Rule Announced

The IAMERS FDA Committee has also been reviewing the proposed regulations concerning the Unique Device Identification System. The proposed rule was published for comment in the July 10, 2012 Federal Register. Comments on the proposed  rule are due by September 10 as they pertain to information collection issues under the Paperwork Reduction Act of 1995 and by November 7, 2012 for the substance of the proposed rule. In many ways the proposed rule follows the general tenets of the Global Harmonization Task force by requiring that each medical device be labeled and that information on the label (e.g., type of device, lot, batch number) be captured in plain text and in a form that automatically identifies and captures information (bar code). Little is said as to when the UDI is to be changed and how the UDI is to be captured on large equipment purchases. While the expected implementation date for Class II devices is expected to be three years after the final rule, the IAMERS FDA committee is working with the FDA on addressing issues of particular concern to our industry. The full proposed rule and comment are readily accessible on the FDA website. (Caution: its lengthy). IAMERS welcomes comments concerning the proposed rule and the proposed requirement of post market surveillance (whereby information concerning the equipment is kept for purposes of product recall).

Medical Device Excise Tax Begins In Five Months

IAMERS met with tax counsel from a senior member on the U.S. House Ways and Means Committee to discuss some need for clarification of the medical device excise tax (currently set for assessment in January 2013. Under the proposed regulations a tax will be imposed on the sale of any “taxable medical device” by its “manufacturer” or “importer” at a rate of 2.3% of the price for which it is sold. IAMERS has asked for a clarification that used and refurbished devices (sold domestically) are not subject to the tax.

CBO Updates Costs of the ACA After the Supreme Court Decision

Following the Supreme Court decision on the constitutionality of certain aspect of the ACA last month everyone with an opinion has chimed in either for or against. Today there is an interesting post reporting on the impact to the cost of implementing the ACA after the Supreme Court Decision. Here is how the Congressional Budget Office (CBO) views the costs changing as States opt in or out of the Medicaid portion of the ACA and other events occur. Continue Reading…

Do you know what BYOD means?

For some it means Bring Your Own Device. For others who experienced network crashes from viruses contributed by people hooking their personal device into the company network it means Bring Your Own Disease or Destruction. In this modern age the mobile device is a wonderful addition to our ability to communicate. But if you are concerned about how these devices might crash the network you may find a recently posted Webinar of interest. Continue Reading…

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