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
Obama Veto Showdown Looms Over Medical Device Tax Battle But even in summer, deals can be cut on Capitol Hill
Mon, 08/03/2015 - 12:26
Although medical-industry trade groups and many House and Senate members are lined up on one side, determined to repeal the medical device tax, the other side might have the final ace: A veto threat by President Obama. Not so fast, say opponents…
Medical Device Makers Express Optimism About the Future... ... but the U.S. regulatory burden is worrisome
Thu, 07/23/2015 - 16:36
Crystal may be clear, but crystal balls, at least metaphorically, are certainly not. The late, great political columnist David Broder of The Washington Post used to run a column at the end of the year tallying up where he had guessed correctly—and…
Study: FDA 510(k) Approval Process Now Averages Six Months For some device manufacturers, third-party reviewers could reduce that to 68 days
Wed, 07/15/2015 - 12:27
If you’ve got six months—and nerves of steel—here’s some good news: You have a 61-percent chance of getting your medical device approved by the Food and Drug Administration (FDA). That’s one nugget of interesting data to be found in a recent Emergo…
FDA’s Shuren Works to Ensure Medical Device Industry Innovators He hopes the Medical Device Innovation Consortium will help
Wed, 07/08/2015 - 14:16
Calling it something of a “culture change” at the Center for Devices and Radiological Health (CDRH), Director Jeffrey Shuren said his team is working hard to find ways to speed approval of new medical devices by, in part, placing more stress on…
FDA Moves UDI Initiative Further Down the Production Line The agency gets this one right
Thu, 06/25/2015 - 14:26
We, and others, like to take the FDA to task for missing deadlines or behaving in ways that are sometimes difficult to fathom. So it’s only fair to give equal space to something when they seem to get it right. Take the agency’s Unique Device…
Congress Crawls Out of 20th Century to Push Bipartisan ‘Cures’ Legislation The 21st Century Cures Act improves the regulatory process
Tue, 06/09/2015 - 11:41
Just when we’d all decided Washington lawmakers won’t accomplish much beyond enjoying their own excellent health insurance coverage, tasty bean soup in the Senate cafeteria, and the best parking on Capitol Hill, it turns out they might actually…
FDA Works to Clarify Device Data Collection Priorities Some post-approval studies can replace premarket studies
Tue, 05/05/2015 - 17:01
(AssurX: Morgan Hill, CA) -- A new FDA guidance issued by the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) offers some helpful detail for device firms uncertain if post-approval studies…
FDA Plays Catch-Up It’s a brave new world of electronic consent
Thu, 04/23/2015 - 14:47
Informed consent (IC) is more than getting a quick signature from a clinical trial participant, the FDA gently reminds industry in a new guidance addressing increasingly complicated electronic IC (eIC) issues. Issued almost simultaneously with…
FDA Gives the MDDS World a Big Break Three free passes for medical device data systems
Tue, 03/17/2015 - 15:30
Sometimes it’s nice to be told what the U.S. Food and Drug Administration (FDA) isn’t going to do. The agency issued a guidance last month that should make anyone building or working with a medical device data system (MDDS) happy and relieved. Can…
Quality Takes Time, FDA’s CDER Reminds Drug Makers Lessening the workload is proving to diminish waste
Wed, 02/04/2015 - 12:21
Scholars still debate how long it took to build the Great Wall of China, but it’s generally agreed it was built in stages between the 5th century B.C. and the 16th century A.D. The Great Pyramid of Giza took about 20 years to construct, according…