Unless you've been on a secluded island vacation, or are working way too hard, you are no doubt aware that the movie "Avengers: Infinity War" is now the owner of best opening weekend at the box office. Touted as the biggest crossover movie ever, it's success will no doubt spawn numerous others. Like for example, the CDRH "super office" at FDA. Okay, okay so it's just reorg. But honestly, would you read this blog if I used that as an intro.
So what exactly is going on in Maryland. Succinctly, FDA decided last year to combine four offices at CDRH into one. CDRH’s Office of Compliance (OC), Office of Surveillance and Biometrics (OSB), Office of Device Evaluation (ODE) and Office of In Vitro Diagnostics and Radiological Health (OIR) will all be combined into one new office called Office of Product Evaluation and Quality (OPEQ). The goal is to make this official before the end of 2018.
And why are they doing this? Ideally, this new structure is designed to remove some of the functional silos within FDA, particularly between the pre- and post-market teams. As Dr. Jeffrey Shuren (Director of CDRH) put it in a recent meeting, this re-structure is designed for the staff at FDA to have “more organic connections and information-sharing”. By the way, if you're wondering where you've heard that comment before, just search the internet for quotes from any Silicon Valley executive ever that's trying (in vain) to justify an open office concept in their lavish new building.
Kidding aside, FDA doesn't have a bad idea here. Their primary goal is to use the old concept of total product life cycle (TPLC) in the regulation of medical devices. The thought is that through the combination of post-market surveillance folks and the pre-market reviewers, you might be able to proactively create safer and more effective products in less time.
By leveraging the knowledge and best practices within a single office, FDA hopes to focus - and thereby more fully engage - its resources. Work currently done in separate offices and branches - premarket reviews, post-market surveillance, compliance and quality - will now be managed by a single team focused on a particular technology. The resulting structure could lead to better policies and guidance from CDRH, particularly for novel, breakthrough technologies.
Does this have the potential to be a disaster if not executed well? Of course it does, it's a reorg for heaven's sake. But like any large institution, FDA has many silos that need to be razed. Anyone that's gone through the review process in the last few years will tell you that submissions routinely get chopped up and parsed out across CDRH, with varying degrees of success. Credit Dr. Shuren and the leadership at CDRH for at least recognizing that the old way of doing things could use some fresh thinking.
Like any big change, we'll have to wait and see if this succeeds in making CDRH more efficient. In the meantime, grab some popcorn and one of those giant sodas that you'll regret drinking midway through, and go find your seat.
Enjoy the show!