The FDA recently hosted a meeting that included industry, government and medical society experts.  The goal of this meeting was to establish a resource for real world data on transcatheter valve replacement technology and also serve as a model for future international cardiovascular device registry collaborations.

There are only four days left for the medical device industry to provide comment, as requested by the FDA, on the topic of extreme weather conditions and medical device safety and quality. Hurricanes, floods, earthquakes, and tornados can pose potential interference with the manufacturing, shipping, storage, or use of marketed devices which is a cause for concern for the safety and effectiveness of devices.

On April 30, 2013, FDA announced a workshop titled “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device” scheduled for June 13, 2013. The main purpose of the meeting is to discuss the agency’s past, present, and future policy on 510(k) modifications. The FDA is inviting external stakeholders to provide discussion and bring examples of actual device modifications to use in developing future policy.

What is the difference between Significant Risk studies (SR) and Non-significant Risk studies (NSR)? Who makes the decision, why do they make the decision and how can it effect a clinical trial? Based on the FDA’s guidance for medical device studies and the Regulations, a SR device:

I ran across this article on Yahoo.com caught our eye.  As taxpayers and a CRO that actively interfaces with the FDA, I thought this would be an excellent blog topic and discussion generator.  Given the projected impact of the sequester, I thought it was interesting that FDA Commissioner Margaret Hamburg recently asked Congress for more funding to help:

It is critical that the group of patients enrolled in a study represent the population that may receive the device once it is on the market. Certain medical devices could elicit different responses depending on gender, according to the federal watchdog agency. Basic differences such as genetics, hormones, body size, diet and socio-cultural issues may play a role in the efficacy of medical devices in patients, according to FDA.

This week is FDA Warning Letter Week at IMARC! Have you had a chance to catch up on the first three blogs that aim to help you response to the FDA? This last blog in the series attempts to take the perspective of the agency when reading your response letters.

This week is FDA Warning Letter Week at IMARC! Did you check out the first two blogs in a series of 4 titled Differences and similarities between FDA Warning Letters and Form 483s and Tips to avoid when responding to FDA Warning Letters and Form 483s? Next learn 10 Tips to consider when responding to a FDA Warning Letter or Form 483:

One way that the Food and Drug Administration (FDA) protects public health and ensures compliance with the Food, Drug and Cosmetic Act is by conducting inspections of clinical trial investigators, clinical trial sponsors, Institutional Review Boards (IRB) and facilities that manufacture, process or pack FDA-regulated products.  At the conclusion of an investigation, a site may be issued a Form 483 or a Warning Letter. Read on to learn the differences and similarities of these forms of communication provided by the FDA to the inspection site.

This week is FDA Warning Letter Week at IMARC Research!  Over the next four days, IMARC will provide the following blogs to help learn and generate conversation: