R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.

 

The REdI Fall 2016 Conference: Slides and Recordings

The Regulatory Education for Industry (REdI) Conference is an FDA-led forum that brings together the regulatory educators from FDA’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) to provide direct, relevant, and helpful information on the key aspects of drug and device regulations. The FDA holds these conferences only twice a year, which doesn't give medical device companies too much wiggle room when it comes to clearing their busy shedules to attend. So if you missed the conference, R&Q will fill you in!

510(k) Pop Quiz!

How well do you know the logistics of the 510(k) process? Today’s blog is interactive, as well as educational! Take this quiz (no cheating!). Comment on the post to tell me how many answers you got right!

How the FDA handles complaints

Complaints from end users to medical device manufacturers are unfortunately a common occurrence. Medical device manufacturers are expected to handle these complaints efficiently and effectively by keeping the end user or patient’s safety in mind. However not a lot of people think about how the FDA has to handle complaints from medical device manufacturers.

HFES Health Care Symposium – What’s New in Human Factors and Usability?

Last week I had the opportunity to attend the Human Factors & Ergonomics Society Health Care Symposium. Since I work on medical devices, I mainly went to the presentations in the medical devices track and found them to be very interesting and educational. The opening keynote speaker, Dr. Ross Ungerleider, talked about practices that foster an environment (particularly in an operating room) conducive to innovative thinking and learning from human error. There were a number of presenters from the medical device industry who shared case studies, lessons learned, and various models for applying usability in their individual companies and departments. We were also fortunate to learn about some changes coming for human factors standards and the latest FDA perspectives on best practices, which I thought I’d share with you this week.

Headaches

The FDA received funding to increase its workforce at the CDRH for 2012 and 2013. They have set aggressive goals to improve the turnaround times for 510K approval. They have instituted programs to retain their employees and to increase the reviewer to manager ratio. My colleagues and I were very excited to hear about it. These changes will make things better for the public and smoother for us, especially after these new employees are fully trained. Good news, right?

Creating Consistency

One major variable med tech companies are faced with today is the unknown of FDA reviewers. It seems like what works for one company doesn’t necessarily work for the rest. And why is this so?

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