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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…
Michael Causey
It’s a growing trend in these United States: paying extra for conveniences such as bypassing the riffraff in airport security lines, or whizzing past mere mortal motorists on pristine, pay-for express lanes.
Where I live in the Washington, D.C. area, the new express road program in Northern…
Michael Causey
A new Food and Drug Administration (FDA) draft guidance, “Medical Device Development Tools—Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff,” outlines a voluntary process for qualification of medical device development tools (MDDT).
The guidance, issued Nov. 14…
Thomas Abrams
You probably have seen many consumer advertisements for prescriptions drugs—on TV, in magazines, or online. Although those ads are expensive, did you know that in 2010, pharmaceutical companies actually spent more money advertising to healthcare professionals than they spent advertising to…
Grant Ramaley
Many of us have heard horror stories about ISO certificates that were fakes, or of medical-device quality system audits being performed by persons who were not competent. A recent report published by the European Commission found that two out of 11 notified bodies were performing so inadequately,…
Patrick Stone
The Food and Drug Administration’s (FDA) “Food Police” will be in full force to secure budget funds for food safety initiatives for FY 2014 as mandated by Congress. More than half of the operating funds will be earmarked for food work.
International food inspections will surely be a focus area…
Mike Roberts
My colleagues and I at LNS Research have spoken to numerous companies during the past several years that have done an admirable job of building compliance into production processes. However, there are still many companies, particularly in the manufacturing sector, that struggle to meet product and…
Margaret A. Hamburg
There are many good reasons to go to Arkansas in September: to visit Little Rock, America’s No. 1 most livable city; or attend the annual Eureka Springs Antique Automobile Festival, to name two. But neither of these reasons are why more than 100 scientists, researchers, government regulators, and…
Paul Naysmith
Arecent call with an old colleague from Europe got me wondering about a question that few are conscious of: Who is the customer of your quality document? Oh boy, did we have an interesting discussion about quality systems.
My friend was developing and reinvigorating his employer’s quality system,…
Dennis Payton
Given the Food and Drug Administration’s (FDA) increased findings for companies that must comply to CFR 21 Part 820—“Quality system,” it’s curious that the oversight body has not offered much guidance about product design control, particularly concerning sections 820.30 and 820.40 of the…
Stericycle Inc.
According to the quarterly ExpertRECALL Index, 48 percent of all medical device recalls reported during the second quarter of 2013 had both U.S. and international components. In addition, the number of device recalls increased 30 percent from the last quarter, resulting in the highest number of…
Bakul Patel
Many medical devices today perform at least one function by using wireless technology to support health care delivery. In telemedicine, for example, a wireless device can enable real-time monitoring of patients from a distance. Data from a patient-worn or implanted medical device goes directly to…
Bakul Patel
For medical devices, the term “interoperability” refers to the ability of various devices to interact, and for electronic health record systems to talk to each other using a common vocabulary. It is similar to the concept of “plug and play” computer attachments such as a web cam or mouse, which…
Margaret A. Hamburg
It’s a small world. Every day, there’s a good chance that some of the food you’re eating came from another country. Fifteen percent of the food we eat, including nearly 50 percent of the fresh fruit and 20 percent of vegetables, is imported each year.
That’s why it’s so important that we do…
The QA Pharm
Editor's note: This is the first in a five-part series exploring issues that affect management’s ability to detect the warning signals of current good manufacturing practice (cGMP) compliance problems in the pharmaceutical industry.
Compliance to current good manufacturing practice (cGMP)…
David S. Buckles, Lawrence Romanell
Disagreements are inevitable in science, medicine—and even life. As part of a regulatory agency committed to public health, the Food and Drug Administration’s (FDA) medical devices center occasionally confronts scientific and policy disagreements among its staff and with the various stakeholders…