February 2014

For Medical Device Companies

Medical Device Clinical Trials – How Do They Compare with Drug Trials?

by Brandy Chittester, IMARC Research, Inc.

It seems like the clinical research world is often thought of in terms of pharmaceuticals. Clinical trials are often referred to in Phases, such as “a Phase 2 study of a new drug” or “a Phase 3 randomized clinical study with a placebo control.” Although clinical trials for medical devices have many similarities to those for pharmaceuticals, there are some necessary differences in the way the trials are designed and carried out. And in some cases, for medical devices, clinical trials may not even be required!

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“3 Loops in 1” as Reflected in FDA Warning Letters

by Cindy Fazzi, MasterControl Inc.

Anyone who keeps an eye on the FDA’s website for enforcement actions and warning letters knows that violations pertaining to corrective action and preventive action (CAPA) are among the most common issues cited by the agency (1).

Many of the citations could have been avoided, or at least mitigated, with the help of a closed-loop or “three loops in one” CAPA process. What is it and why is it critical?

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Responding to FDA 483s: Do’s, Don’ts, and When to Call in a Remediation Partners

by Lisa Weeks, MasterControl Inc.

Operating under the oversight of the FDA and other global regulatory agencies creates a climate of transparency for regulated companies; any misstep can result in severe consequences such as product seizures, recalls, or company closure. Therefore, the way you respond to FDA Form-483 observations, warning letters, and other critical events is vital to your company's survival. Having a sound quality management system in place is critical, but when remedial action is necessary, time is of the essence. After all, you have only 15 working days from the receipt of the 483 to respond!

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