An article in MD+DI dissects the difference between a regulatory strategy and a regulatory plan by simply asking five questions to regulatory affairs expert, Michael Santalucia. We found this article to be very interesting, considering many may not have examined these differences before, which may lead to better regulatory understanding and success. The five questions, and summarized comments from the article, are listed below:

A recent DeviceTalk blog on MD+DI caught my attention. The article’s title, “What’s in a Medical Device’s Name? For Patients, a Lot” speaks to the fact that for some patients a lifetime is spent with their medical device. This is especially true for those with chronic conditions, like Type I diabetes.

The drumbeat for change at the FDA continues.  According to an article in MD+DI, leaders of Minnesota companies and venture capitalists believe the industry faces a dire future unless the FDA changes its policies and procedures.

Recently MD+DI published an article, “The U.S. Medical Device Industry in 2012: Challenges at Home and Abroad.” The article speaks to the Industry being a source of jobs, innovation and revenue for Americans. In addition, U.S. has been the longtime world leader for the medical device industry.

The area of combination products is an exciting expanse of potential innovation and discovery for both the medical device and drug industries. But what exactly are combination products? According to 21 CFR 3.2(e), they are defined as:

There has been much talk recently about the proposed changes to the regulatory and healthcare systems in the U.S. for the medical device industry. A recent MD+DI article by Nick Woods, director of Woods Medical Media, describes these proposed changes and how they might impact our industry. Woods points out that while President Obama’s PPACA document contains 2074 pages filled with words, for most, one number holds the most weight. The 2.3% sales tax on medical devices expected to come into effect a year from now. The industry seems to be united against this new tax. Our blog last October highlighted Senator Scott Brown’s plight for a repeal, and there have been numerous other calls to have it eliminated.