Finding the Right Regulation

Thursday, September 29, 2011

This week, Pathway Genomics announced that they had obtained "FDA classification and registration" after submitting their Establishment Registration form.

Our first instinct, for better or worse, was to mock their announcement. It's one thing to announce that you believe FDA review is not necessary. It's quite another thing to represent your self-submitted database entry as if it represented some type of FDA review. That's just kicking one in your own goal.

There is a larger and more interesting point in all of this, however. Pathway's mistake appears to stem from a mis-reading of the CFR. Their interpretation is intuitively sensible, but one that is directly at odds with how FDA has regulated this exact type of product in the past. If you're trying to figure out how your product is to be regulated, how are you supposed to know which regulation applies?

Pathway's establishment registration record references 21CFR 864.3250, titled "Specimen transport and storage container." That regulation identifies such products as:

"...a device intended to contain biological specimens... during storage and transport in order that the matter contained therein can be... used effectively for diagnostic examination"

Well... that's exactly what Pathway's device is, right? It's intended to contain a biological specimen so that it can be used for a diagnostic examination. Case closed, right? Doubtful.

The trick with reading the CFR is that a more specific regulation may change the applicability or interpretation of a more general one. If you're only reading the more general reg, you won't necessarily see any reference to how and when the specific one applies. 864.3250 doesn't say "unless that device is being used to stabilize nucleic acid" but other regulations make it clear that this use is considered to be a higher risk that transporting biological specimens in general. See 866.4070 and 862.1675. Both those regs have language that seems to indicate that they apply to blood or PCR testing only... but that's not how they are being enforced.

At the risk of tooting our own horn, the best way to find out whether your interpretation of the CFR is correct is to ask someone with experience working with your type of product. That doesn't have to be a consulting shop, however... FDA will be happy to tell you which regulations apply.

FDA's input generally comes in one of three forms:

  1. In a voluntary, private conversation, such as during a pre-IDE meeting
  2. In private warning and untitled letters
  3. In public warning / untitled letters when you're really gotten their attention

It's possible you could have a preference for seeing what you can get away with, but we tend to steer our clients toward the first option. Our experience has been that it's easier to know what your regulatory burden will be before you make big plans and issue press releases. But your mileage may vary.

Tags: 510(k), FDA, IVD

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