Need help and a Specific Regulation relating to 510(k)

[DjfunkmasterG]

First i want to thank the folks whom helped me with my 510(k) issue a few weeks back. Appreciated

Now I have a new dilema. In January the company I currently work for was cited in a 483 for shipping a device without 510(k) approval. (my original thread was to address this problem)

We did the new 510(k) but have not received any feedback, however, the owner is continuing to ship product to buyers, and also continues to modify the machines without design control.

A very heated argument erupted this afternoon relating to a GDP issues along with the blatant falsification of an MIR (Manufacturing inspection report) by the Mfg Manager.

As the QA Director I immediately siezed that unit from going out the door. With the owner out for the day, I said I will take any heat for that unit not shipping and I continue to point out we shouldn't be shipping because the current model we're mfg and selling is not 510(k) approved.

However, I am having massive trouble finding a specific passage or verbage in relation to this dilema.

My biggest concern is not for myself, but for the employees. They're out of the loop and kept in the dark by management, and I know I can get this place on the right path, and I am not willing to give up and walk away, but I need some specific verbage direct from the FDA/CFR that I can use to put a stop to this... If I have to I will go to the FDA... job be damned, but I want to exhaust every avenue before I have to sail that particular ship.

Any help or guidance is greatly appreciated.

 

[Stijloor]

A Quick Bump!!

Can someone help?

Thank you very much!!

 

[DjfunkmasterG]

Still need help with this... been beating my head on my desk all day. Can't find a specific regulation or passage that says we cannot ship, yet the FDA claims we can't, and of course the CEO/Owner I think knows this and is purposely flaunting the system.

 

[isoalchemist]

From the FDA Website on how to market your device. Premarket Notification. Closetest I can find to if it's not approved you can't sell it.

Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the Act) and does not exceed the limitations of exemptions in .9 of the device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9). There is no 510(k) form, however, 21 CFR 8071 Subpart E describes requirements for a 510(k) submission. Before marketing a device, each submitter must receive an order, in the form of a letter, from FDA which finds the device to be substantially equivalent (SE) and states that the device can be marketed in the U.S. This order "clears" the device for commercial distribution.

Until the submitter receives an order declaring a device SE, the submitter may not proceed to market the device.

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm

 

[DjfunkmasterG]

Thanks...

I did find that, but was looking for "specific wording" because the CEO is th ekind of guy who wants the specific words that says "Item/device cannot be shipped until 510(k) is approved.

Without that wording he is going to continue to ship the product.

I have argued what you had posted with him, emphasing "Clears" and he is just shaking his head at me.

Any suggestions? other than turning him into the FDA?

 

[MIREGMGR]

The specific law-language underlying that guidance statement is at 21CFR 807.81.

Note that actions inconsistent with a guidance may be subject to an argument about interpretation and to wiggle-room, but actions inconsistent with the law may be criminally prosecuted.

Edit: as referenced above, "Until the submitter receives an order declaring a device SE, the submitter may not proceed to market the device" seems exceedingly clear to me.

In any case, it's commonly known and extensively precedented that FDA considers marketing of an unapproved device to be illegal, and willful action of this type, depending on circumstances, to be criminal.

 

[DjfunkmasterG]

Believe me, I know that... but trying to explain it to this man is like talking to a bag of rocks. I put the 510(k) in, but no word back on it, and he continues to insist they go out the door.

Overriding my place as Director of QA.

he feels since his unit was the first ever to market and all other units are based off his esign he has free right to do what he is doing and nothing will stop him unless it states clearly "YOU CANNOT SHIP UNTIL YOUR 510(k) IS APPROVED!"

He wants those exact words in writing from the FDA even though he was shut down once for doing this, 6 years ago. He figures that even though the FDA noted it as an observation, without them expressly telling him he can't ship another item, he will continue to ship until the hammer comes down.

I am trying to get him to understand the repercussions, but he just gives me the wave off and a annoyed sighing grunt.

I have repeatedly explained the risk he is in, and that he could cost the staff their jobs, but he just desn't care and he wants that statement from the FDA, as I worded (per his word) otherwise.... SHIP SHIP SHIP.

 

[Stijloor]

Believe me, I know that... but trying to explain it to this man is like talking to a bag of rocks. I put the 510(k) in, but no word back on it, and he continues to insist they go out the door.

Overriding my place as Director of QA.

he feels since his unit was the first ever to market and all other units are based off his esign he has free right to do what he is doing and nothing will stop him unless it states clearly "YOU CANNOT SHIP UNTIL YOUR 510(k) IS APPROVED!"

He wants those exact words in writing from the FDA even though he was shut down once for doing this, 6 years ago. He figures that even though the FDA noted it as an observation, without them expressly telling him he can't ship another item, he will continue to ship until the hammer comes down.

I am trying to get him to understand the repercussions, but he just gives me the wave off and a annoyed sighing grunt.

I have repeatedly explained the risk he is in, and that he could cost the staff their jobs, but he just doesn't care and he wants that statement from the FDA, as I worded (per his word) otherwise.... SHIP SHIP SHIP.

Best advice? Polish your résumé!

You don't want to get caught up in this! :mg:

 

[MIREGMGR]

Yep. Time to bail out.

 

[DjfunkmasterG]

Yeah, that is what i figured. Luckily I have been hit up by 8 head hunters in the last 22 hours since I posted my resume online yesterday.

This is just a nightmare, and a major migraine.

Thanks for your advice and help everyone.

*** off topic, sort off - I remember my days of being an individual contributor... I didn't have these kind of problems. Maybe it is time to roll back to a senior lead Specialist, as opposed to a Manager or in my case a Director.

It just seems too many companies are taking too many risks with the FDA and CFR/QSR (this company isn't the first i have worked for to pull this stunt, but the 1st in which i was the director of QA.)