You have to feel for clinical labs after last week. They do such important work for so little money and now FDA is going to add all this regulation and run them out of business. Or at least that's the impression many of them seemed to be under by the second day of the LDT meeting.
Hearing dedicated health professionals fret about 501's and Q-R-whatevers was heartbreaking, to be sure. You know they're doing their very best to advance science and medicine and it's not tough to understand their fear of oppressive new rules and bureaucracy. They raise a very valid point that maybe everyone else should be making an honest effort to understand what they are already doing well. Point taken.
What clinical labs really need to understand is this: FDA is not interested in shutting you down.
Somehow or other, most legit scientists and medical practitioners will be allowed to continue doing what they are doing. After all, many of the current efforts in clinical labs probably represent the best practices and science we have developed.
What is actually going on here is that FDA is interested in narrowing the definition of "laboratory-developed test" so that it only covers tests that actually are developed in clinical labs.
The proposed changes in enforcement are intended to address a small (but significant) group of for-profit diagnostic manufacturers who are unduly using the goodwill that real clinical labs have earned. These operators are manipulating the latitude regulators give to the practice of medicine for the purpose of offering products that have not undergone the appropriate level of scrutiny. Many of these products are therefore of marginal and/or undetermined value. FDA's worries about risks and patient harm are well-founded.
What's difficult about the current situation is that FDA is being incredibly indirect about signaling that they want to continue granting wide latitude to real clinical labs. You can't hold them to a promise they haven't actually made, but as someone who "speaks IVD" I can assure you that they have hinted strongly that they do not want to meddle in your affairs.
So please take heart, clinical laboratorians. FDA does not represent a lethal threat to your practices. In point of fact, this change is likely good news for you because FDA seeks to curb the practice of companies trading on your reputation. Somehow, FDA will craft some regulatory work-around that covers what you do and exempts it from undue additional burdens. I don't know what form that measure is going to take, but it will be there.