Special 510k Update - Cease Sales and Distribution until a Decision is Rendered?

A

aoldendo

#1
Hello all:

My company is preparing a Special 510k to update the FDA on all changes to our product during the past few years since the original 510k clearance.

The question I have is this: during the 30 day clock in which to review a Special 510k, must a company cease sales and distribution until a decision is rendered?

And hypothetically speaking, were the FDA to come back and require a traditional submission (in the instance the Special 510k were not sufficient), would our company be required to cease sales and distribution for that 90 day clock?

Thanks for your help..

Sincerely,
A
 
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G

George Weiss

#2
The special 510k, is like a pilot calling the traffic tower, (FDA), to change course.
Most pilots would wait for approval before changing course.
Reporting changes made in the last few years, and now calling the traffic tower, (FDA). OMG!
Your changes may be minor changes, or major changes in medical device regulation speak.
I can verify the 30 days for special 510K
I can verify the 90 days for 510K
The FDA instructions after these guidance days pass, is to call and check, "what is the status?"
.
Almost all/all Class I, and some Class II devices are exempt from special 510k per FDA,
so you must be taking about your Class III device, right?
Your comments also speak of possible rejection of special 510k filing.
I hear this whisper in the background, "Recall" or "Market Withdrawal".
Medical Device 101 from the FDA 229 pages of guidance @
http://www.fmdic.org/events/devices101/20090605w.pdf
.
I am just adding the PMA item:
30-day Notice and 135 PMA
Supplement—814.39(f)
This is used for modifications to manufacturing procedures
or methods that affect the device’s safety and
effectiveness. If FDA does not respond within 30 days
after notification, the change can be made
referenced page 9 @
http://schiffandcompany.com/userfiles/fusra-6ed-201-215(2).pdf
I have no direct answer, but some concern.
 
Last edited by a moderator:
M

MIREGMGR

#3
...during the 30 day clock in which to review a Special 510k, must a company cease sales and distribution until a decision is rendered?

And hypothetically speaking, were the FDA to come back and require a traditional submission (in the instance the Special 510k were not sufficient), would our company be required to cease sales and distribution for that 90 day clock?
As George discusses, if you are actually noncompliant at present, the situation you outline in theory should not occur (though of course in practice it does), and therefore the FDA has no published guidance on how to handle it. The FDA's policy is one of not accepting any noncompliance, even when an effort to come into compliance is under way. This of course leads to lies-of-omission in discussions with them, because any admission of past or current noncompliance can result in enforcement action.

If your documented and internally accepted stance is that you regard the Special submission as timely, appropriate and likely to be accepted, given the Bluebook discussion of how a filing may become appropriate in respect to accumulated minor (memo to file) product evolutions over time, then my understanding would be that continued marketing would be acceptable. In the worst case, the level of trouble your company in theory could be in won't be any different whether you continue sales or halt them.

If however the FDA has an unfixable problem with the Special and demands a Traditional, then you're in effect on notice as to noncompliance. That's a much more problematic situation. I think then you'd have to stop sales, at least, and maybe do a recall. In that case, I'd think you might want to get expert legal advice.
 
A

aoldendo

#4
George and Miregmgr,

Thanks for your input.

I will try and give a little more background on the situation we find ourselves in. Our device is Class II. The position we've taken internally is that which Miregmgr described thusly:

"If your documented and internally accepted stance is that you regard the Special submission as timely, appropriate and likely to be accepted, given the Bluebook discussion of how a filing may become appropriate in respect to accumulated minor (memo to file) product evolutions over time, then my understanding would be that continued marketing would be acceptable."

We do not believe the device has changed appreciably from the original 510k either in function, material, technology, labeling, etc.

However, I also appreciate the frank assessment of what might happen were FDA to find unsolvable problems with the Special 510k. This is important to know as we assess the benefits and risks of updating the original 510k.

Regarding advice on this topic, would DSMICA be able to help?

Thanks,
A
 
B

Biobry

#8
"We do not believe the device has changed appreciably from the original 510k either in function, material, technology, labeling, etc."

I realize I'm jumping into this a little late, but if you believe what you stated, then based on the Memorandum #K97-1 "Deciding When to Submit a 510(k) for a change to an existing device", the Special 510(k) may not be necessary at all:

"In effect, manufacturers need to submit a new 510(k) only when a change, or the sum of the incremental changes exceeds the §807.81(a)(3) threshold, "could significantly affect the safety or effectiveness of the device.""

Why do you feel the Special 510(k) is necessary in the first place?
 
B

Bruce Banner

#9
I agree, if you have documentation supporting a filing was not necessary, then there is no basis to file.

However if you are going back on that documentation, then you need to rationalize why it was the wrong decision to begin with and go from there
 
D

drewsky1

#10
In regards to this topic of Special 510k, is it required that the predicate be a device that the company submitting the Special 510k be the manufacturer? Or can one submit a Special 510k with a predicate that they do not manufacturer?
 
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