The Big 510(k) Non-Announcement

Friday, January 21, 2011

The long-awaited and much-discussed "Plan of Action" was posted this week after a pre-launch publicity bump by none other than the President himself. All of us regulatory types stayed glued to our computers to find out how our work would be changing over the next year. Much to my disappointment, it looks like things, at least for us IVD types, are likely to stay pretty much status quo.

There are a couple of areas that caught my eye as possibly interesting developments even though none are earth-shaking:

  • An online labeling database
  • Third party reviews
  • Unique identifiers
  • Pre-clearance inspections and manufacturing data in 510(k)s

And a couple more than give me pause for concern:

  • Class IIb concept put on hold
  • Additional layering-on of scientific advisors and training

The online labeling database could be a significant resource and would be a welcome relief from having to just hope that companies post something on their websites.

The other interesting note is FDA's renewed interest in third-party reviews. Third-party review has been out of bounds for most IVD products since almost all IVD submissions include clinical data. The specific proposal here calls for evaluating the "list of device types" that can qualify for third party of review so they may not be considering adding in those with clinical data… but a girl can hope.

It also looks like unique identifiers are going forward. This presents a challenge for many products; for IVDs it could be a huge headache depending on how far this is taken. Will we need to take this as far as identifiers for each reagent bottle in a kit? Plates for PCR machines? We’ll be anxiously looking forward to the guidance document FDA plans to issue.

Buried in the preamble, FDA keeps open the possibility of performing pre-clearance inspections and requiring some manufacturing data in 510(k)s. If these changes go forward they will require us to re-evaluate whether the 510(k) process provides a strategic advantage over a full PMA. I look forward to hearing more about these plans.

I was disappointed to see the Class IIb concept put on hold. Having this additional category would be very helpful for novel IVD products that straddle the Class II/III risk line. The idea of disallowing reference to predicate devices that have been recalled or no longer on the market seemed like a "no duh" for me. But apparently that change, too, is now on the back burner.

The aspect of the document I found a bit disturbing is the suggestion that FDA is not trained adequately or needs additional scientific advisors. I'm not convinced that adding new layers of stakeholders will do anything to expedite the regulatory process.

Although it’s always hard to say "no" to learning more, lack of FDA training seems to me to be an overblown issue. FDA regularly meets with scientists, companies and attends conferences. In my experience they often know more than we do in industry because they see so many of us come through their doors with our latest ideas. Access to training and expertise is a good thing, but adding more of this good thing will not necessarily produce better outcomes.

Tags: 510(k), CDRH, Industry, Obama Administration

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