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:

Focus on safety, and leave the question of efficacy to post-market studies; this recent recommendation comes from the former commissioner of the FDA, Andrew Von Eschenbach. As imagined, this suggestion has created quite a stir in the industry and many are weighing in with their thoughts.

It’s official! According to the new guidance released on the FDA’s website all applicable clinical trials initiated on or after March 7, 2012, informed consent documents must be in compliance with the new requirement in 21 CFR § 50.25(c) and include this specific statement that refers to the trial’s description on http://www.clinicaltrials.gov:

We ran across this interesting article in MD+DI.  According to a report released by the Emergo Group, the average time it takes to obtain 510(k) clearance has risen steadily in recent years.  The findings in the report indicated that the average number of days from submission to clearance increased every year from 2006 to 2010.

After reviewing warning letters issued to investigators and sponsor-investigators last year, through FDA’s Bioresearch Monitoring Inspection Program, IMARC’s clinical monitoring team has assembled the 2011 “TOP 10” list. This list is not intended to point fingers at investigators, but rather, to document the non-compliance trends in an effort to raise industry awareness of improvement needed. Whether you are a sponsor, a monitor, or an investigative site, everyone has a stake in the outcome of an FDA BIMO inspection.

It seems as though these days, everyone has a Facebook page, Twitter account, etc. In fact, even public groups and companies are using social media in similar ways and in abundance.

The tentative agreement on reauthorizing the Medical Device User Fee & Modernization Act (MDUFMA) is long awaited good news! IMARC covered the story of how the FDA missed the MDUFMA proposed deadline, January 15th, in a previous blog. But, luckily it looks like the medical device industry and the FDA were able to find common ground.

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.

MedCity News released an article about Nanofiber Solutions development of scaffolds used for organ transplants. The company, a spinoff from The Ohio State University, boasts the first synthetic nanofiber transplant in the world, and hopes to grow in its market of artificial organ transplants.

The FDA released its four main priorities for 2012, and the focus of the FDA will be: