It hit the headlines in a dizzy twist on words. The CEO of St. Jude put the cart before the horse in warning investors that he was expecting a warning letter from FDA before one was actually even issued! According to a report on MedCity News, this type of announcement apparently has no precedent. Have you ever heard of a company proactively telling Wall Street they’re going to receive the dreaded warning letter before receiving it- or even a FDA form 483? This was something that was on the mind of analyst Bob Hopkins of Bank of America.

 “One reason I think it’s going to change is we’re starting to see change already.” This statement was made by FDA Head, Dr. Margaret Hamburg, after meeting with senators and med-tech leaders about industry concerns. According to an article by the Star Tribune, the overall tone after the meeting was optimistic and hopes that the FDA Safety and Innovation Act signed into law will help loosen the logjam for approving medical devices.

One of the biggest concerns for any device on the market is the possible risk to patients and adverse events tied to the product. In order to improve the quality of information tied to specific medical devices distributed in the US, FDA released a proposed rule for devices to carry a Unique Device Identifier (UDI).  According to the press-release the code is a unique numeric of alphanumeric sequence specific to a device model and also can be tied back to a lot or batch number and expiration date. The FDA provided an example of what a UDI would look like on a medical device label.

Risk analysis is essential in regards to investigational devices. The goal of risk assessment is to remove a hazard or reduce the level of its risk by adding precautions or control measures, as necessary. It’s an important process which can identify problems with investigational products and help eliminate costs, time, and risk associated with recalling the product- but most importantly, protect patients.

You might be surprised to find that the good ole toothbrush is a long time trusted medical device. The FDA Medical definition of a manual toothbrush is “a device composed of a shaft with either natural or synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.”  This seems to be pretty simple and straight forward! However, recently the International Organization for Standardization (ISO) released new standards for this manual device. The new requirements and test methods include:

Many medical device companies have decided to launch their investigational products initially in Europe.  Representing one-third of the global medical device market, the European Union market provides a significant opportunity for medical device start-up companies.  However, according to an article in MedCity News, it can create many challenges that require proper preparation.

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.

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.

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.

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