Thoughts on the 510(k) process

FDA recently held an all day conference about the 510(k) process. It was also available to people who didn’t attend (like me) via the web and has also been archived. My reaction follows:

In-vitro diagnostic (IVD) devices (such as blood analyzers) are just one type of device and are quite different from most other devices since IVDs don’t interact directly with patients. I don’t know the breakdown between IVDs and other devices.

Post market surveillance was described as an issue that FDA would like to improve. I believe it is essential. For example, a typical assay may get cleared for 510(k) by running a few hundred specimens during evaluations. Yet, the number of patients assayed with that device is likely to be many millions. So only a small sample is being tested at the beginning of the device history. So here is what’s needed – I don’t know the best way of making it happen.

FDA needs to collect data on:

  1. A usage factor. For IVDs, perhaps the number of reported results for a particular assay by manufacturer and model.
  2. All events, whereby an event is either:
    1. Some error with the assay
    2. Some effect that is an error that is connected to the assay

FDA needs to provide guidance so that event reporting contains the severity and frequency of the event, with FDA guidelines as to how to classify events.

FDA then needs to analyze this data as to the error rate for:

  1. Assays that harm patients
  2. Assays that have other errors such as failure of the system without patient harm

FDA can then provide reports as to which assay and errors require improvement. This is how many IVD companies improve their products (with the FRACAS process).

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