Today, FDA has issued a draft guidance document: Draft Guidance for Industry and FDA Staff – Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions.
A few of us got a sneak preview of this document last week when it got leaked to an AMP discussion group. Some folks reading this blog are already up to speed on what is in the document, but as of today, it's official.
For those just reviewing the draft guidance today, I suggest a nice cup of chamomile tea before cracking it open. You might also want to deliver the news to your CEO with some Benedryl-laced coffee. If your business depends on sales of RUO products or you are a Laboratory Developed Test (LDT) and depend heavily on the availability of RUO products as components of your test, this document could dramatically change your business plans. It lays out some very significant changes in enforcement of existing regulations.
The message in this draft guidance is clear. A product that is labeled RUO should only be sold to those doing research. It should not be sold to customers that are taking the materials and creating clinical diagnostics (i.e., LDTs). Many of us are unclear just how dependent we have become on RUO products and will, no doubt, be surprised to discover how many we are using and for what purposes. This transition is going to be a bit painful.
The lack of enforcement around sale of RUO products into clinical diagnostics has created an industry-wide Achilles heal that FDA has just signaled they are ready to kick with pointy-toed boots. This one’s going to smart for quite awhile and, depending on how it is enforced, could hobble more than one business or laboratory.
We're going to be talking about this change for months to come and it's a safe bet we'll have several more blogs coming up where we'll discuss the potential impact on the various groups within our industry that will be affected by this change in enforcement. Stay tuned for more in the coming days.