Resources

by Tony Chen Yet another consent decree was announced today by the FDA. This time, it is Terumo Cardiovascular Systems, makers of heart machines that circulate blood during heart surgery.  Signed by Terumo’s CEO and Vice President of Quality Assurance, the consent decree: “prohibits the company from manufacturing and distributing two heart-lung bypass systems and […]

On February 14, 2011 the FDA published notice (press release) of the long awaited final rule for medical device data systems (MDDS). The real news behind the final MDDS rule is not the less-burdensome path to market trumpeted by many news stories, but the FDA’s stated intent to exercise “enforcement discretion” with regard to those […]

Hot on the heels of calls from Congress, the President,and prominent medical device industry players to streamline the 510(k) approval process so as to make it easier for innovative treatments to make it to market, comes a new study from the Cleveland Clinic questioning the ability of current FDA safeguards to protect the public from […]

by Tony Chen Due to popular demand, we’ve started a website that’s focused solely on avoiding and responding to 483s. Check it out at FDA483s.com. It’s still in beta phase and the paint is still drying, but I think you’ll get the picture of what this could be – a one-stop shop for resources, presentations, […]

By the time a consent decree comes along, it’s no longer a discussion about responses to Form FDA 483s observations replete with well-turned phrases—it’s about a DIY Network renovation—a complete makeover. It’s a “gut-it” approach, as never before, which exposes the cracked foundation and termite-eaten beams weakened over time. This is because the common element […]

The strategic reasons behind the acquisition in the works for Sanofi to purchase Genzyme are clear. It was a matter of fixing a sale price that reflected the true current and future value of Genzyme. For those of us in the quality assurance and regulatory compliance professions, there has been the curiosity of how the […]

(Chicago) March 7, 2010 — Though it can cost hundreds of thousands of dollars to respond to a single Form FDA 483, many pharma manufacturers aren’t taking some of the basic steps needed to avoid being cited, according to new research published by FDAzilla, one of the Web’s leading sources on the business of the […]

For some companies, manufacturing is a crapshoot. There is little basis for confidence that the right equipment, materials, components, people, and records will be at the right place and the right time to begin manufacturing. And once manufacturing starts, a crystal ball is as good as anything to divine whether the product batch will be […]

The FDA has spent much of January focused on American medical device issues. In particular, they have been reviewing the regulatory status of several classes of medical devices already on the market. The latest segment of the industry to be subjected to FDA scrutiny is the manufacturing of external defibrillators. External defibrillators have gained a […]

The ease of application development afforded by the extensive community surrounding portable devices like the Apple iPhone/iPad has led to a surge in medical device-like apps being released for smart phones and tablets. An article published by Siren Interactive quoted a MobiHealthNews study that found more than 7,000 medical apps available for the iPhone in […]