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
Cybersecurity Management Expectations Clarified by the FDA The Common Vulnerability Scoring System can help
Tue, 04/11/2017 - 12:02
The FDA has made it abundantly clear that it expects medical device manufacturers and other life sciences firms to have strong cybersecurity management programs. Since the FDA hasn’t always been clear on what it expects on a granular level, the…
New CDER Guidance Could Affect Quality Management Efforts Be proactive in anticipation of new leadership and direction at the FDA
Tue, 02/28/2017 - 12:03
Former FDA Chairman Robert Califf, M.D., stepped down on Jan. 20, 2017, and it’s not always easy to predict what the Center for Drug Evaluation and Research (CDER), or any FDA agency, will accomplish under a new chairman. Efforts at quality…
Risk Management Programs: What the Latest Wave of HIPAA Fines Means It was a busy year for Health and Human Services
Tue, 12/20/2016 - 11:34
The Department of Health and Human Services (HHS) hit hospitals and other healthcare delivery networks hard in the pocketbook with a wave of big fines zeroing in on security risk management issues between July and October. Is this the end of the…
How Strong Is Your QMS Program? New international Meddev rules challenge complacent organizations
Mon, 11/07/2016 - 15:16
It’s time to get your compliance programs in order to meet some looming international regulatory compliance demands, experts including former Food and Drug Administration officials say. Having a firm grip on quality management processes—especially…
RAPS Review: FDA CDRH Director Shuren Talks Priorities The agency’s 2017 goals featured at regulatory professionals conference
Mon, 10/24/2016 - 14:06
The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Director Jeff Shuren outlined the agency’s ambitious 2017 goals at an important session that was part of the conference of the Regulatory Affairs…
FDA Eases Up a Bit on Enforcement Gas Pedal Fewer warning letters, but CAPAs continue to garner the most citations
Thu, 11/19/2015 - 12:52
Medical device warning letters and domestic inspections continue to show a slow decline, according to a new report issued by the U.S. Food and Drug Administration (FDA). The number of medical device-related warning letters dipped to 121 during…
FDA Answers (Some) Medical Device Cybersecurity Concerns For premarket approval, it’s mostly common sense—with a few caveats
Tue, 11/10/2015 - 12:58
A new FDA guidance calls on the medical device community to be more proactive when it comes to developing a solid set of cybersecurity controls to ensure safety and efficacy for users. However, the agency isn’t putting the entire onus on medical…
FDA Touts Improved IDE Review Stats Nearly 75 percent of Investigational Device Exemption studies are fully approved within two cycles
Wed, 10/07/2015 - 16:26
Ironically, the U.S. Food and Drug Administration (FDA) is sometimes wary of issuing guidances out of concern it will appear to be imposing new rules that will stifle innovation, according to Ken Skodacek, a policy analyst for the Clinical Trials…
FDA Pilot Program Encourages Quarterly Malfunction Summary Filings
Tue, 09/01/2015 - 16:37

FDA will be taking applications starting Sept 1, 2015, looking for makers of class I and suitable class II medical devices to participate in a pilot program to file malfunction reports in summary form quarterly. Get on the stick, though, if…
Steady Medical Device Profit Climb, Especially for the Big Boys A medical device tax may, or may not, affect profits
Wed, 08/12/2015 - 10:32
A new Government Accounting Office (GAO) report, designed to shed light on what effect the medical device tax will have on the industry in the future, might have done a better job of taking us under the industry’s financial hood. The GAO, the…