Category Archives: Devices

We Learned 5 Things from 2014 FDA and EU GMP Drug Enforcement Actions

2014 proved to be another busy year for the FDA.  We asked Barbara Unger, President of Unger Consulting and Editor-in-Chief of GMP Regulatory Intelligence, to summarize her key take-aways from the enforcement actions of the FDA and EU in 2014. Here’s Barbara: Continue reading

How Does the Government Shutdown Impact FDA Inspections?

Half Open, Half Closed

The government is still shut down, though the FDA is still about half-open.  The question is: which half?

The government shutdown is now on day 9, with no end in sight. Based purely on our 483 sales data in the last 9 days compared to September data, we’re seeing a significant drop. It makes sense that FDA inspections have either slowed down significantly or stopped completely. It was reported earlier this week that 45% of the entire staff would be off. Continue reading

Differences Between Medical Device and Pharmaceutical Clinical Trials – A Primer

Given that the size of the pharmaceutical industry at times overshadows the medical device market, it is no surprise that companies that are just getting started in device development sometimes need clarification about the regulatory implications and practical differences between pharma clinical trials and medical device clinical trials. We’ve put together a basic primer to help guide readers through the most important steps along the medical device regulatory pathway to market, and to explain the disparities between it and the clinical trial process for drug approval. Continue reading

Today Show Hypes Medical Device Reprocessing Safety Issues

A recent segment on the Today show highlighted public concerns regarding hospital acquired infections – specifically, those that can be contracted from medical devices and surgical instruments. The report presented the case that even if proper sterilization processes are followed, there remains a strong chance that surgical equipment will be contaminated with blood, tissue, and fluids from previous patients. Continue reading

The FDA Matters “Guide to the User Fee Reauthorization Process”

The prescription drug (PDUFA) and medical device (MDUFA) user fee programs, which run for 5 years, must be renewed by September 30 of this year (last day of the current fiscal year).  House committee staff has just released a 205-page first draft of reauthorization legislation. The Senate has starting releasing drafts on specific issues and has a March 29 hearing scheduled. Continue reading

FDA Doubles Medical Device User Fees

Is the pathway to quicker medical device regulatory approval or clearance to be found through the establishment of higher fees on the part of the Food and Drug Administration? It would seem so, given that the FDA has recently announced a new program that will double the amount of the user fees currently paid by the biggest players in the medical device industry. The new five-year medical device user fee deal, which is still awaiting Congressional approval, would seek $595 million from medical device manufacturers – a jump from the previous $287 million called for by the last five-year agreement. Another key component of the agreement is the requirement that the FDA meet with device companies through the process to address concerns and set goals for reducing review times. Continue reading

Medical Devices and the EU Path

Over the past decade it has become common for some medical device companies to introduce a product to the European market prior to attempting to gain FDA approval and sell the same device in the United States. In some cases, depending on the classification and technology of the device, Europe can provide a quicker route to marketability. Continue reading

FDA Partners With Private Industry Groups To Streamline Medical Device Approval Process

The FDA’s search for a more efficient medical device approval process continues full steam ahead with the latest announcement that the Administration is looking to leverage partnerships within the industry in order to achieve this particular goal. Although the relationship is being described as ‘informal,’ the FDA will be working together with Biocom in order to bring greater ‘clarity, predictability and transparency‘ to the pathway used by medical device manufacturers when bringing products to market. Continue reading

FDA Matters Mailbag: Hatch-Waxman, Biosimilars, User Fees and More

Over the last month, FDA Matters has covered a wide-range of FDA-related topics: the agency, industry, and Congress, as well as medical innovation, user fee reauthorization legislation, food safety and post-market surveillance. The response has been great: FDA Matters has many new readers and I received a number of interesting questions. Continue reading

FDA and Industry Relations: A Mix of Frustration and Respect

There is no one answer to the question: what is the state of FDA-industry relations? FDA Mattershears some say: FDA does what industry asks it to do, the agency is a puppet. Others say that FDA is obstinately blocking industries’ path to new, better and innovative products. Yet others say FDA is misguided at points, but well-intentioned and most often right. Continue reading

Will Increased User Fees Result in a Faster, Safer Approval Process?

How long should it take to review a medical device for public use? The FDA’s current average, 73 days, is too much time, according to the medical device industry.  Patient advocacy groups however, claim the current process is rushed and at times negligent. A safer, faster approval process would certainly benefit everyone, but enhancements cost money. That’s where user fees come in. Continue reading

User Fee Reauthorization: FDA Is In Trouble If 2007 Repeats Itself

Starting this week, the House will hold hearings on reauthorizing the drug and medical device user fee programs that fund one-fourth of the agency. While user fees have become largely non-controversial, this “must-pass” legislation is Congress’ opportunity to consider dozens of other FDA issues, some controversial and many time-consuming. Continue reading