All Features
Tamar June
In a previous column, Michael Causey looked at the FDA’s relatively ho-hum guidance on social media. Since then, the agency has issued an interesting warning letter to a Utah-based dietary supplement maker for, among other alleged infractions, “liking” off-label claims made about its product on…
Russ King
Food and Drug Administration (FDA) medical device recalls are on the rise. An increasingly active FDA coupled with an increase of medical device software components is adding up to new challenges for manufacturers. It’s important to understand how the FDA uses IEC 62304, an international standard…
Taha A. Kass-Hout, Jeffrey Shuren
In addition to food and drugs, the FDA has regulatory oversight of tens of thousands of medical devices ranging from bandages and prosthetics to heart valves and robotics. These products are used by millions of Americans, and they are essential, well-performing tools of modern healthcare, but…
Michael Causey
Medical device manufacturers would be well-advised to address any risk with potential home-use products during their design phase, according to an August 2014 guidance from the FDA.
As the agency notes, “Failure to adequately consider potentially hazardous situations during the design of home-use…
The QA Pharm
After nearly 20 years helping the biopharmaceutical industry to regulatory enforcement by implementing an operational and sustainable quality management system, I have come to the conclusion—at the most fundamental level—that there are three quintessential elements required for success. I call…
Russ King
The FDA recently released a new draft guidance document for medical device data systems (MDDS). The FDA defines MDDS as “hardware or software products that transfer, store, convert formats and display medical device data. An MDDS does not modify data, and it does not control the functions or…
Howard Sklamberg
Since July 9, 2012, when President Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA), a group of colleagues and I have had an urgent mission: implement Title VII of the statute. This section gave the FDA new authority to better protect the global drug supply chain,…
Michael Causey
The U.S. Food and Drug Administration (FDA) won’t enforce compliance with regulatory controls that apply to medical device data systems (MDDS) and medical image communications devices, recognizing the “low risk” they pose to patient safety and the importance they play in advancing digital health…
Most of us, at one point or another, have been faced with making a decision to purchase a software application. Whether a simple application to manage your schedule or a more complex quality management software, the challenge is the same: How do you decide if a software application meets your…
Michael Causey
If someone out in there in the wild wonderful world of the web takes a potshot at your drug or device, the first thing to do is take a deep breath and think. Any crisis communications executive worth her salt will tell you it’s often best to let the attacker eat silence rather than draw more…
Margaret A. Hamburg
The World Health Assembly is the decision-making body of the World Health Organization (WHO), attended every year by leading government health officials from its 194 member nations. Recently, I was pleased to participate as a member of the U.S. delegation in the 67th meeting of this important…
Janet Woodcock
In recent years, there have been important advances to ensure that therapies for serious conditions are approved and available to patients as soon as sufficient data can show that the therapies’ benefits outweigh their risks. Despite the progress, there is much more work to be done. Many…
Not knowing the answer to the question posed in the title of this article has led many medical device manufacturers to undertake expensive and unnecessary retesting of their previously certified products.
In Annex 1 of the “Medical Device Directive 93/42/EEC—Essential Requirements—Section 2,” the…
Howard Sklamberg
To keep the food supply safe, have safe, effective, and high quality medical products, and decrease the harms of tobacco product use, we have to work with the rest of the world.
As the Food and Drug Administration’s Deputy Commissioner for Global Regulatory Operations and Policy (GO), I oversee…
Kelly Kuchinski
Editor’s note: A webinar on this topic will held on May 29, 2014, at 2:00 p.m. Eastern / 11:00 a.m. Pacific. Register here.
Food and beverage manufacturers have seen a considerable number of changes over the last decade. Mergers and acquisitions have expanded the footprint of many food and beverage…
FDA
Have you sometimes wondered if that “wild caught” salmon actually came from an aqua farm? Or if the “U.S. catfish” in the display case might have been born and raised in Vietnam? Is that “red snapper” actually red snapper and worth the premium price?
Scientists at the U.S. Food and Drug…
Grant Ramaley
Congress has mandated that every two years the FDA will have inspected nearly every medical device manufacturer on planet Earth that sells to the United States. This isn’t happening. Some have the illusory hope that the Medical Device Single Audit Program (MDSAP) will remedy this.
There just aren…
Michael Causey
It’s March 2014, but you could forgive medical device company leaders if they’re still smarting a bit from a generally tough 2013. Several new studies indicate a low level of mergers and financing occurred last year, which could slow product innovation down the line.
Also there was a drop in 2013…
Margaret A. Hamburg
We all know that just as every person is different, so too is every disease and every drug. And so we weren’t surprised by the results of a new study published in the Journal of the American Medical Association.
The study found that the FDA used a range of clinical trial evidence when approving…
Michael Causey
You shouldn’t need Barney the giant purple dinosaur to remind you of the playground mantra “sharing is caring,” but maybe the medical device industry needs to do some quick Netflix streaming of back episodes.
The Institute of Medicine (IOM), already working with more than a dozen drug makers, the…
Mike Figliuolo
PowerPoint is the devil’s instrument, and when you use it, you risk becoming a musician in his demonic orchestra. All of us are required to give presentations in some form or fashion at various points in our careers. If you’d like to succeed in those efforts, there are three things you should never…
Michael Causey
Those of us in and around Washington D.C. like to tell folks in the days leading up to a president’s State of the Union (SOTU) address that the speeches rarely matter and are generally forgotten while the teleprompter’s still warm.
Then we analyze them to death for a few days. I don’t mean to…
Michael Causey
Let’s start with what most everyone agrees on: The Unique Device Identification (UDI) program is a swell idea. It gets a little trickier after that.
In extensive comments, the Advanced Medical Technology Association (AdvaMed), Boston Scientific, and Merck, among more than a dozen other…
Dennis Payton
Some of the shortest descriptions in the Food and Drug Administration's (FDA) CFR 21 Part 820—“Quality System Regulation” are found in Section 820.30 and Section 820.40, totaling about a page of information about design and document controls. However short, these two sections outline some of the…
Michael Causey
Given the fact that the FDA probably doesn’t know what it plans to do in 2014, predicting their actions is challenging, to put it mildly.
With that slightly weasel-like caveat, it’s worth noting three events in 2013 that will almost certainly impact 2014.
CDRH’s Office of Compliance…
