I sat down tonight, as I do every night that I write a blog post, and I started reading the prior posts from my colleagues. I had every intention of writing on a different topic tonight, but something struck a chord with me when I looked through the blogs. They all had something in common. It’s something that we as regulatory and quality folks struggle with and love at the same time. It’s the topic of precedence.

The US FDA clears medical devices through the 510(k) pathway on the basis of substantial equivalence to predicate devices. As Ryan pointed out in his recent blog on Mobile Medical Applications, there are companies that are bull-dozing the way for new software developers by becoming some of the first cleared apps on the market. They are helping to define the regulatory process for these types of devices. Other companies will be able to cite these initial devices as their predicates, and have a more clear understanding of the requirements. In this case, setting precedence is one of the best things that we could do to help the industry grow.

However, as Deb pointed out in her recent post on biocompatibility, we can’t always rely on doing the same things that the people before us did. Sometimes, companies have been doing things the same way for a long time because that’s just the way they do it. Until one day when it finally gets challenged by your quality engineers, internal auditors, or worse, the FDA. Many people point at the FDA for changing their views. How many times have you heard people say that the pendulum is swinging over to the other side? But you should always be objective and challenge any decisions you make. Maybe the last time you got a lazy reviewer and the details of the biocompatibility just slipped through? Maybe we’ve gotten too comfortable with the way things are done around here?

This is why it always helps to have a fresh set of eyes. Think of independent reviewers on design team meetings. Why are they there? To review the details of the project and ensure that all of the sweat and tears that the team has put into the project are kosher, but also to bring up issues that may have been overlooked.

On one hand, setting precedence is good because it gives us a basis of something to work off of, and allows us to make predictions about the future. However, we should always stay fresh and be able to (nicely and politely) challenge things when necessary.


- Sherri

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