Michael Causey’s picture

By: 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 express lanes.

Michael Causey’s picture

By: 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A new Food and Drug Administration (FDA) draft guidance, “Medical Device Development Tools—Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff,” outlines a voluntary process for qualification of medical device development tools (MDDT).

Grant Ramaley’s picture

By: 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 the European Commission found that two out of 11 notified bodies were performing so inadequately, they were ordered to stop issuing CE certificates.

Patrick Stone’s picture

By: 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 funds will be earmarked for food work.

Bakul Patel’s picture

By: Bakul Patel

For medical devices, the term “interoperability” refers to the ability of various devices to interact, and for electronic health record systems to talk to each other using a common vocabulary. It is similar to the concept of “plug and play” computer attachments such as a web cam or mouse, which are made to operate with different brands and models of computers.

Although it may seem abstract, successful interoperability among medical devices can improve patient care, reduce errors, and lower costs.

Margaret A. Hamburg’s picture

By: Margaret A. Hamburg

It’s a small world. Every day, there’s a good chance that some of the food you’re eating came from another country. Fifteen percent of the food we eat, including nearly 50 percent of the fresh fruit and 20 percent of vegetables, is imported each year.

John Roth’s picture

By: John Roth

In an earlier article, I explained how the Food and Drug Administration’s (FDA) Office of Criminal Investigation (OCI) works when a small portion of the industry fails to adequately respond to regulatory action.

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