Michael Causey

Editor and publisher

James Michael Causey’s been a journalist since he started his own neighborhood newspaper in the 1970s. In addition to quizzing FDA officials for the past 10+ years, he’s also interviewed political satirist Art Buchwald, FCC Chairman Reed Hundt, SEC Chairwoman Mary Schapiro, and is the past president of the Washington Independent Writers. Causey is the editor and publisher of eDataIntegrityReport.com and is a contributing writer on the AssurXblog.

Tue, 04/11/2017 - 12:02
Medical Device Makers Urged to Play Nicer by Sharing Data Speak up now, or don’t complain later
Wed, 02/19/2014 - 11:46
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),…
Much Ado About SOTU Analysis: No need for State of the Union analysis
Mon, 02/03/2014 - 11:47
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…
Medical Device Industry Identifies Problems with FDA’s UDI Initiative Inconsistencies and hair-splitting with the term ‘required’
Tue, 01/21/2014 - 12:14
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,…
FDA’s Promises for 2014 For starters, increased international operations, and label enforcement
Wed, 01/08/2014 - 10:30
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…
FDA’s Voluntary Compliance Improvement Program Receives Tepid Response Too much stick, not enough carrot?
Mon, 12/16/2013 - 17:11
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.…
FDA Accepting Comments on ‘Medical Device Development Tools’ Guidance describes framework and process of voluntary CDRH qualification
Thu, 11/21/2013 - 17:24
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…
New Guidance Offers Clarification on IDE Requirements To help determine if an investigational device application is warranted
Mon, 09/09/2013 - 15:26
School bells have sounded the death knell of summer across the land. But as we’ve noted before, the U.S. Food and Drug Administration (FDA) didn’t take much time off to enjoy surf and sand. The agency capped a busy season last week by issuing a new…
You Got Electronic Medical Device Reporting Questions? The FDA has (some) answers
Wed, 07/10/2013 - 10:52
In a new 47-page guidance the Food and Drug Administration (FDA) appears to be doing its best to cover the waterfront for medical device manufacturers who need to better understand the complex medical device reporting (MDR) requirements. Topics…
FDA to Plug Holes in Medical Device Security Systems It's depressingly easy to figure out hundreds of passwords
Thu, 06/20/2013 - 14:27
The Internet giveth and the Internet taketh away. For years, we’ve been hearing about the benefits online tools will bring to the medical industry, especially at hospitals and physicians’ offices. Many of those promises have come true, and it’s…
Federal Regulators ‘Patent’ Another Bad Idea Unexamined patent applications stack up due to filched funds
Wed, 06/05/2013 - 16:48
The shell game called the federal budget added another nut recently as media reports revealed that during the last 20 years, approximately $1 billion in fees paid by patent applicants has been diverted from its proper use at the United States…