From my point of view it's mainly going to be around continuing compliance of existing products what with the introduction of the newer RoHS requirements, the 4th edition of the EMC standards and updates to ISO 13485. We have already seen some of our own clients needing support in these areas in order to ensure their product which may now be several years old, continues to be compliant to the various directives in place. I can see there being a big push once everyone has gotten their heads around the changes and it starts having a business impact on individual companies.

Arjun Sharma Awaiting FDA new Cybersecurity guidelines which are currently only in draft.

Ken Powell IP. The entire area of IP litigated and adjudicated by courts with little if no clinical diagnostics industry knowledge and its impact on health care is very, very disturbing. Here are not so well known statistics: Over 70% of clinical diagnostic decisions are based on a diagnostic result. Yet diagnostics account for less than 3% of all US health care spend.

So courts with their virtually non existent knowledge of genetic testing play the legal games and rules and put those people (including their own families) at serious risk.

Going forward I see no change. I have closely monitored the FDA's position on Laboratory Developed Tests ((LDTs) since 1992. The FDA has not done one single thing except hold meetings, issue some "guidance" and that's it.

Appalling.

Robert Christensen read my book, FDA You Were WRONG

Julie Omohundro Ken, on the surface, it would seem that the congressional response to the guidance thus far tends to support the theory that FDA has not acted on LDTs because there has been no political will to act. What is your take on this?

Ken Powell Julie - I have limited confidence on Congressional action not only on LDTs, but on other areas. A classic example are anti-drug laws designed to stop illicit drug use. Remember who and when began the so-called "War on Drugs?" In your opinion, despite thousands State and Federal laws, do we have of a drug problem in the US? Of course we do. The same can be said of firearm laws. Laws may support politicians and politics, but they rarely if ever solve the fundamental, underlying problem. Many congressional initiatives have been directed at LDTs without any impact at all. Like I said and we have discussed, the FDA has been at this for more than 26 years. The solution clearly will not be found in passing more laws, from my experience and in my opinion.

Julie Omohundro Ken, I agree about drugs and guns, but I'm missing a clear connection to LDTs.

I have been thinking that FDA is looking at regulating LDTs, rather than continuing to exercise its enforcement discretion. I have also been thinking that it is looking at regulating them pretty much like other medical devices. I have to say that, whatever you think of FDA's regulation of medical devices (and pharma), I don't think it falls into the same category as government efforts related to drugs and guns. Am I missing something here?

Regardless, do you have any thoughts on where the solution might be found?

Ken Powell Julie- My comment was directed at Federal/State "laws" being the solution to a given problem. I am sorry you didn't make the connection. You only need to look at the abundance of existing commerce laws and the enormous fines paid for willfully breaking them by commercial reference labs for fraudulent billing and behaviors even prior to CLIA and the FDA decade by decade. Given that health care spend on clinical diagnostics is less than 3%, I can't imagine the other health care sectors that are similarly exposed.
A solution would be LDT regulations, rather than LDT "guidance" and "discretion" that has been used regarding LDTs. This would naturally open the up the FDA to the American Protection Act and initiate a lengthy and complicated process going forward. By continuing to issue "Guidance" and using "Discretion", the FDA side steps this.
No simple solution. But then what else would you expect when government (and the requisite politics and interests) becomes involved?

Julie Omohundro Ken, I assume you are talking about AIPA? That never even occurred to me. Thanks for bringing it up. And I think you meant to say that a solution would be regulation, rather than regulations? This is based on my understanding that FDA already has all the regulations needed to regulate LDTs, but hasn't actually regulated them, so far. It seems to me that this is most likely a resource issue from FDA's perspective?

Ken Powell Julie - After searching through my LDT files dating back to the early 90s, I discovered that I was referring to the Administrative Procedure Act (APA), not the AIPA. you can research this, but long story short is that the FDA can side step the APA numerous and some would say arduous requirements by issuing "guidance", which is not subject to the APA. It is a little more complicated than this, but that again is "the short (strategic) story".

Julie Omohundro Ken, thanks. This has been very educational for me.