FDA Features

Grant Ramaley's picture
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...
Michael Causey's picture
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...
Margaret A. Hamburg's picture
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...
Michael Causey's picture
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...
Mike Figliuolo's picture
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...
Michael Causey's picture
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...
Michael Causey's picture
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...
Dennis Payton's picture
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...
Michael Causey's picture
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...
Michael Causey's picture
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...
Michael Causey's picture
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A new Food and Drug Administration (FDA) draft guidance, “Medical Device Development Tools—Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff,” outlines a...
Thomas Abrams's picture
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...
Grant Ramaley's picture
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...
Patrick Stone's picture
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...
Mike Roberts's picture
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...
Margaret A. Hamburg's picture
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....
Paul Naysmith's picture
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...
Dennis Payton's picture
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...
Stericycle Inc.'s picture
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...
Bakul Patel's picture
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...