Thanks. I'll look into it.

Yeah things they do, rules they make, make me wonder if they are trustworthy, including when it comes to regulating diagnostic testing.

Just because you have rules in place doesn't mean you follow the rules or have enough staff to enforce the rules, which leaves room for error. Maybe you get what I'm saying?

But like I said, I will read it. And I thank you for mentioning the section.

I now officially surrender. I have always wondered why you all spend hours on end in these battles, I have to say it was cathartic. Lol!

RobertHively wrote:

Heh. Enforcement is part of the FDA's role. I was a consultant for pharmaceutical companies for years. I have sat in audits with FDA agents and defended the documentation generated, the testing performed and the procedures followed. Trust me, people take this VERY seriously. My clients were usually companies which were one bad audit away from being shut down because they didn't take it seriously before.

There is room for interpretation. There is not room for error... if that makes sense. The companies use the guidance to develop their own tests. They may interpret parts of the guidance to define what testing will be done and how it will be done, BUT that interpretation must be defensible using accepted risk minimization techniques. Once a company (or more specifically a project) defines how they are interpreting the guidance, and how they will perform their testing or manufacturing there is NO room for error. I've seen companies be strung up because they defined their process, but one rogue employee did something they didn't think was important, but did not follow the process they had defined.

victor809 wrote:

I'm both. Lol! They aren;t credible and they're incompetent. Like with most agencies it's a revolving door over there. One year you're working for a company in the pharmaceutical industry, the next year you're at the FDA writing the regulations for your buddies. The incompent part is what I typed above.

I'm also over it. I'm good on the expert opinions.

I just felt like I should read it and provide a response. Bc I know how you get when I dont call or write. I still read the threads, most of the time I just dont have anything to say.

Read more type less. Rule one of noobs.

RobertHively wrote:

Alright I read that section a couple times, definitions, labeling, requirements...

A lot of these sections referred me to to other sections which I did not read, which would take quite a long time to read and piece together a readable document.

But the fact that the FDA has procedures wasn't really my question...

In the past, I have read that the FDA is horribly understaffed. So unless they have the power to audit a great number of companies, multiple times, within a given time time frame, what teeth do the regulations have? I would guess a lot of companies skirt the regs knowing that the FDA doesn't have the time or manpower to catch them. I'm sure the FDA tries to make an example out of some of them from time to time to maintain compliance in the industry. The cops do the same thing for speeding tickets but people still speed everyday.

RobertHively wrote:

Victor I agree with you for the most part but we have temporarily relaxed the regs on many things and cut corners on many things at the direction from the top.

I don’t know exactly what that means in terms of testing, but I do when it comes to telemedicine, facility inspections etc.

I am worried about this. What sounds good can go terribly wrong if you discount why the regs were there in the first place.

teedubbya wrote: