All Together Now – FDA Builds Devices Super Office

Team work

The biggest difference between the FDA way and the rest of the world is the separation of activities into device assessment, which comes first and involves FDA reviewers from the various Offices of Device and IVD Evaluation and manufacturer inspections by the separate Office of Compliance, which comes later, sometimes much later. Postmarket surveillance is also handled separately by the Office of Surveillance and Biometrics.

And the offices really don’t talk to each other much. It’s all in Silos.

So CDRH, in the biggest overhaul in many years, is rearranging things around product types – merging all of these offices into one so-called Super Office of Product Evaluation and Quality and grouping staff within into teams around device categories. Soon, CDRH will look something like this:

The aim is to bring together FDA experts into teams centred around product groupings. So one team will be involved in the regulation of devices throughout their entire life cycle. FDA’s Total Product Lifecycle (TPLC) database has for a long time collated information about individual devices from initial 510k or PMA through audits and postmarket actions including warning letters and recalls. This implements that into working arrangements – sort of TPLC with a human face.

FDA calls this “create an agile infrastructure that can adapt to future organizational, regulatory and scientific needs”.

Australia’s TGA in several rounds of reorganisation over recent years flirted with functional organisation of the agency, going the opposite way and regrouping into premarket, postmarket and audit functions. And it didn’t work. Ultimately TGA put things back the way they work best – with an integrated Devices Branch.

It’s all very logical and should provide for a better, more integrated regulation – which is in the interests of both industry and the public.

FDA will implement the restructure over the next six months – aiming to be done by the end of September. Expect some short term disruptions, and some changes in contact points (look for updates in CDRH’s Management Directory)


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