MDR Rules Change Revealed in Warning Letter

[MIREGMGR]

This law-firm blog post http://www.fdalawblog.net/fda_law_b...ears-to-disavow-the-two-year-presumption.html discusses an interesting and significant change in the FDA's interpretation of their MDR guidance document. My guess is that every US device manufacturer will need to understand this change, and many will need to revise their MDR procedure.

 

[Stijloor]

A Quick Bump!

Feedback? Comments?

Thank you very much!!

Stijloor.

 

[lfrost]

This law-firm blog post http://www.fdalawblog.net/fda_law_b...ears-to-disavow-the-two-year-presumption.html discusses an interesting and significant change in the FDA's interpretation of their MDR guidance document. My guess is that every US device manufacturer will need to understand this change, and many will need to revise their MDR procedure.

Miregmgr, This is some disturbing news. Those companies who thought they were safe with their stated MDR policy and procedure will now find themselves possibly looking at further action by the FDA! I for one am glad that my company's MDR policy did not use the window offered!

Thanks for the information,
lfrost

 

[Ronen E]

This law-firm blog post http://www.fdalawblog.net/fda_law_b...ears-to-disavow-the-two-year-presumption.html discusses an interesting and significant change in the FDA's interpretation of their MDR guidance document. My guess is that every US device manufacturer will need to understand this change, and many will need to revise their MDR procedure.

Does the issue of a single warning letter, to a single company, actually constitute new binding policy in the absence of guidance revision? Sure it may be a trend indicator, but does it have to be construed as comprehensively binding? And what is the legal status of all this? I mean, would it stand a court appeal? (Sorry for my lack of maybe-basic knowledge of the USA legal system)

Ronen.

 

[Wes Bucey]

This law-firm blog post http://www.fdalawblog.net/fda_law_b...ears-to-disavow-the-two-year-presumption.html discusses an interesting and significant change in the FDA's interpretation of their MDR guidance document. My guess is that every US device manufacturer will need to understand this change, and many will need to revise their MDR procedure.

One of the things that irritates me about dealing with regulatory agencies is that the regulated organizations are sometimes victims of some individual martinet in the bureaucracy who takes it upon himself to engage in mission creep and expand the rules by adding his own peculiar interpretation. I am sorry to confess that I have often counseled "discretion is the better part of valor" when encountering such a situation, reasoning that it is less expensive to knuckle under to this bully than to engage in a war which ends up being a pyrrhic victory when it is won in a court or an appeal.

I don't recall the details, but a couple of years ago, one company DID take on the FDA and won, but it was a long and costly battle for the company, while there was no penalty for the FDA people who made an erroneous call.

As much as I would like to believe in Superman's ". . . never ending battle for truth, justice, and the American way," the fact is I still counsel my clients caught in a battle with a government agency to remember wars are rarely won by a single battle and to explore all options before entering into pitched battle with an agency that has virtually unlimited resources and can close down the business, shutting off income to fight the battle.

 

[Ronen E]

One of the things that irritates me about dealing with regulatory agencies is that the regulated organizations are sometimes victims of some individual martinet in the bureaucracy who takes it upon himself to engage in mission creep and expand the rules by adding his own peculiar interpretation. I am sorry to confess that I have often counseled "discretion is the better part of valor" when encountering such a situation, reasoning that it is less expensive to knuckle under to this bully than to engage in a war which ends up being a pyrrhic victory when it is won in a court or an appeal.

I don't recall the details, but a couple of years ago, one company DID take on the FDA and won, but it was a long and costly battle for the company, while there was no penalty for the FDA people who made an erroneous call.

As much as I would like to believe in Superman's ". . . never ending battle for truth, justice, and the American way," the fact is I still counsel my clients caught in a battle with a government agency to remember wars are rarely one by a single battle and to explore all options before entering into pitched battle with an agency that has virtually unlimited resources and can close down the business, shutting off income to fight the battle.

And this is supposed to be the leading democracy in the world?...:mg:

Edit: These were my naive 20 seconds of the day.

 

[Wes Bucey]

And this is supposed to be the leading democracy in the world?...:mg:

Edit: These were my naive 20 seconds of the day.

I wish to point out we Americans have done this to ourselves as we vote for zealots who openly express a desire to limit our freedoms. These "people" [somehow "people" seems too dignified a term] perform some demagoguery in which they claim they know better than the general public and enough folks who yearn to have someone else think for them say, "Wow! This candidate can do my thinking for me." and proceed to vote them into office. These elected know-it-alls hire bureaucrats who rightly think, "Hey! This guy is really my boss, not the people who voted for him. If I model my decisions after him, my job is safe."

This is the kind of thinking and acting that filters down from bureaucrats behind long mahogany desks to the twerps who come to our door to assure we toe the line. When the guys at the top are a little bent, it's like a game of "telephone" as it goes down the line, getting more and more divergent from the original intent.

In our own industry of Quality, we have a term for the monsters created at ground level - Kwality Kops, the Keystone Kop lookalikes who get a thrill when they can shout, "Gotcha!" at the slightest infraction instead of seeking a way to help prevent infractions.

 

[MIREGMGR]

Does the issue of a single warning letter, to a single company, actually constitute new binding policy in the absence of guidance revision? Sure it may be a trend indicator, but does it have to be construed as comprehensively binding?

How to apply the rules and guidances is generally decided by FDA's senior management, legal team and professional advisors. It's always been the case that there's been a set of interpretive understandings as to rules applications. The FDA puts a large amount of internal effort (training, documentation, reviews, discipline) into wringing individual judgement and initiative out of their field inspectors and filing examiners, and making those individuals hew exactly to the managerially determined policies. There's plenty of history since 1976 (the inception of the current law) of evolutions of such interpretive understandings based on internal and external study-conclusions as to the effect of the prior FDA stance vs. FDA's understanding of the intent of the law.

As to whether such information is applicable in an instance other than the one where it's already been applied, the only certain way to know that is to ask FDA. My past experience has been "yes", but perhaps others will have different experiences.

And what is the legal status of all this? I mean, would it stand a court appeal?

That's a question for a lawyer, but my understanding is that generally the courts give broad latitude to the FDA, which is designated in the FD&C Act as that law's enforcement body, to interpret details and apply that law as long as that application isn't plainly in contravention of the law.

 

[Wes Bucey]

As to whether such information is applicable in an instance other than the one where it's already been applied, the only certain way to know that is to ask FDA. My past experience has been "yes", but perhaps others will have different experiences.

And what is the legal status of all this? I mean, would it stand a court appeal?

That's a question for a lawyer, but my understanding is that generally the courts give broad latitude to the FDA, which is designated in the FD&C Act as that law's enforcement body, to interpret details and apply that law as long as that application isn't plainly in contravention of the law.

The various regulatory agencies have changed tactics over the years. It used to be a citizen or a corporation could apply to a government agency for a binding advance ruling on how the agency would view a certain action by the citizen or corporation. My investment bank counted on this a lot in getting IRS and SEC rulings on proposed actions by our clients.

Somehow, those agencies woke up to the fact that other entities would seize upon those "private" rulings as precedents for similar activities by others. Courts would rule against an agency trying to retract a ruling and thus were born "loopholes." I made a large part of my income by searching such rulings for loopholes my clients might use.

To forestall such activity by loophole searchers, the agencies stopped issuing binding rulings and frequently reversed rulings and interpretations of long standing, throwing many regulated industries into disarray, not a happy state.

Winning a legal battle is chancy and ALWAYS expensive. That's why you see so many manufacturers meekly paying fines because the legal battle may be even more costly than the fine. "Right" frequently falls by the wayside in the service of "expedience."

Be aware I am NOT cynical, just practical when it comes to risk assessment vis a vis regulatory agencies.

 

[Jen C]

Just came across this old thread, since I'm deep in the process of reading guidance documents and regulations to prepare updated MDR/recall SOPs for our company. I thought I'd point out for anyone else who happens upon this thread that the new US MDR draft guidance issued July 9, 2013 does formally rescind the 2 year assumption ? you now need to request an exemption if you want to avoid reporting additional malfunctions of the same type, regardless of the timeframe in which no injuries have occurred.

Sorry, can't post links to the updated guidance since I don't have enough posts.