Michael Causey’s picture

By: Michael Causey


s expected, the FDA is shifting more of its regulatory focus toward medical device reporting (MDR). In an Oct. 1, 2014, letter, the agency’s Baltimore district office hit Baltimore-based Electronic Development Labs for not having a MDR procedure. Bad idea. The company may not have recovered very well, either.

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By: Jeff Mazik

If you have been procrastinating on setting up electronic submissions for your adverse event reports to the FDA, you might want to reconsider that decision. Earlier this year, the FDA published its final rule on MedWatch/eMDR reporting.

Gary Minks’s picture

By: Gary Minks

Medical device manufacturers seeking global access for their products can face significant challenges in meeting the regulatory requirements of multiple target markets. The approval process can be even more time-consuming when individual regulatory authorities require an independent audit of a manufacturer’s quality management system, refusing to accept audit reports from the same facility prepared for submission to a regulatory authority in another jurisdiction.

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By: Tamar June

The landmark Food Safety Modernization Act (FSMA) just keeps getting more and more important. Earlier this month, the Food and Drug Administration (FDA) unveiled four proposed amendments that will likely make a tough law even tougher.

Multiple Authors
By: Taha A. Kass-Hout, Jeffrey Shuren

In addition to food and drugs, the FDA has regulatory oversight of tens of thousands of medical devices ranging from bandages and prosthetics to heart valves and robotics. These products are used by millions of Americans, and they are essential, well-performing tools of modern healthcare, but occasionally they present a safety issue due to risks not identified in prior studies, a malfunction, a problem with manufacturing, or misuse.

Michael Causey’s picture

By: Michael Causey

Medical device manufacturers would be well-advised to address any risk with potential home-use products during their design phase, according to an August 2014 guidance from the FDA.

Michael Causey’s picture

By: Michael Causey

The U.S. Food and Drug Administration (FDA) won’t enforce compliance with regulatory controls that apply to medical device data systems (MDDS) and medical image communications devices, recognizing the “low risk” they pose to patient safety and the importance they play in advancing digital health.

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By: Devin Brent Ellis

Most of us, at one point or another, have been faced with making a decision to purchase a software application. Whether a simple application to manage your schedule or a more complex quality management software, the challenge is the same: How do you decide if a software application meets your needs if you don’t know how the software truly functions?

Margaret A. Hamburg’s picture

By: Margaret A. Hamburg

The World Health Assembly is the decision-making body of the World Health Organization (WHO), attended every year by leading government health officials from its 194 member nations. Recently, I was pleased to participate as a member of the U.S. delegation in the 67th meeting of this important group in Geneva.

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