Worldwide Medical Device Regulatory Updates

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That\'s why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you\'ll enjoy the content.

FDA Reopens Comment Period for Microbiology/Medical Countermeasure Device Evaluations

The US Food and Drug Administration is seeking further comment on its proposed approach for evaluating highly multiplexed microbiology and medical countermeasure diagnostic devices.

The agency’s request follows a public meeting in mid October covering performance evaluations of these devices. Now, the FDA is seeking additional feedback on a concept paper on its proposed evaluation plans for these devices, “Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices.”

Specific areas of focus include:

Clinical application of highly multiplexed microbiology devices, as well as public health and clinical needs
Device evaluation, including methods to evaluate clinical and analytical performance of highly multiplexed microbiology devices, as well as validation methods when positive specimens are not readily available
Reference databases, including quality criteria for establishing accuracy and methods for setting up and maintaining databases

The initial deadline for comments on this issue--September 13, 2011—has now been extended to December 21, 2011.