Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File"

W

wangyang

#11
Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

Dear all:

I have another question: If the design change occurs during the 510(k) review process, do i have to notify the design change to FDA and submit the related materials to FDA, or i just have to keep silent and document the design change according to FDA's guidance document<Deciding when to submit new 510(k) for the existing device>

I prefer the later choice, because our device is changing very fast, and FDA's review time is very long for us. If i choose to submit the related material of design change to FDA, the review time will be enlarged with no limit and without stop.

However, i don't know if there is any regulation put any restrict on such behaviour, can you give me some commends?

Any commends will be appreciated.
 
Elsmar Forum Sponsor
M

MIREGMGR

#12
Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

If the design change occurs during the 510(k) review process, do i have to notify the design change to FDA and submit the related materials to FDA, or i just have to keep silent and document the design change according to FDA's guidance document<Deciding when to submit new 510(k) for the existing device>

I prefer the later choice, because our device is changing very fast, and FDA's review time is very long for us. If i choose to submit the related material of design change to FDA, the review time will be enlarged with no limit and without stop.

However, i don't know if there is any regulation put any restrict on such behaviour
The FDA's legal expectation will be that the design for which they approve documentation will be the one that's marketed. The 510(k) process is legally structured around the assumption that the product design is completed and therefore fully understood.

If a change is made that they determine after the fact should have been notified to them, they will regard your product as adulterated. The usual course of action at that point is a required recall, a Special 510(k) submission and a rigorous review, plus possibly an inspection. They might go so far as to nullify the original 510(k) and require a re-submission, though that's rare.

I think you'll find in a review of FDA regulatory actions over the past year or so that their expectations for notification of product changes after 510(k) approval have greatly tightened, and their tolerance for wrong judgment calls has become very thin. A number of mandatory recalls have been based on this issue. The FDA's forced recall and scrapping of many tens of millions of dollars of Steris sterilization systems originated with un-notified changes after approval.

If your design is "changing very fast", and if those changes are substantial, how do you know that your submitted product and process validations and your clinical trial information are factual for the final product?

Of course, if the frequent changes are unambiguously trivial, this won't be a problem for you. Your post makes it sound to an outside observer, though, as if you suspect that some of the changes might be considered to be gray-area at best.
 
W

wangyang

#13
Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

Thank you for your post ,and now i know that FDA want the design finished before a 510(k) is submitted, and i agree with you for such view, however, i can't find any FDA's regulation or guidance document exatly on such issue. And the only regulation for "when to submit a new 510(k) is "at least 90 days before you intended to market the device", what do you think about it?

And you also mentioned that the design modification should not be significant if you only decide to document the design modification. I think yu are right, but the question is , if i make a design modification in the 510(k) review process, and i find that the design modification is minor, do i have to notify the FDA reviewer about the change, or i only need to document it.

Anyway, i really appreciate your view and you give me some light on such issure, and i hope you can give me more information about what you think?
 
M

MIREGMGR

#14
Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

i can't find any FDA's regulation or guidance document exatly on such issue.
Many elements of every regulatory system I've worked with are implicit, or based on a common expectation of interpretation or understanding. To some extent I suppose that's unavoidably culturally and experientially dependent. I regard the matter at hand as clear in the system of rules.

And the only regulation for "when to submit a new 510(k) is "at least 90 days before you intended to market the device", what do you think about it?
The FDA is allowed up to 90 days for a basic review...if no problems arise...and it would be illegal for you to market without having received clearance. So, naturally you need to file at least 90 days before you will be able to market.

if i make a design modification in the 510(k) review process, and i find that the design modification is minor, do i have to notify the FDA reviewer about the change, or i only need to document it.
Are you completely confident that an FDA reviewer after-the-fact would conclude that there is no relevant difference between the product documentation you submitted and the product you're marketing, in any respect that may affect safety or effectiveness? If yes, then you don't need to notify.
 
G

gurumuni - 2010

#15
Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

Hi Rakma,

the information provided by you is useful however, I would like to know whether a 510(k) was required for the packaging change or not?

We are planning to make some packaging changes and your input would be highly appreciated
 
A

AnnieB

#16
Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

I would go back to the FDA guidance on when to submit a 510(k) for a modification to guide your discussions with the reviewer on the current submission.

Regarding the 90 days, the formal name for the 510(k) is premarket notification. Back in the day, (late 80's, perhaps...) the language in our 510(k) submissions was along the lines of, "by way of this letter, we inform the FDA that we will be placing this product into interstate commerce in 90 days". If I remember correctly, we were able to start marketing at that 90 day mark even if we hadn't heard from the FDA.

Things have changed...
 

Ronen E

Problem Solver
Staff member
Moderator
#17
Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

Hi,

I just inquired with DSMICA regarding a change we are making to our 510(k) cleared device. They recommended referring to the FDA flowchart in "Deciding when to submit.." (which I already had) and sending an Add to File to the referenced 510(k) to FDA! This was the first time I heard of this terminology. Then i saw your forum and joined it. I am now wondering, should I document the change internally or send this add to file to FDA. The change is in the packaging of the device components: originally the device components that were sterile were packaged in individual pouches and then the pouches were packaged in a box labeled a kit. Now we want to put those devices ina single tray, sterilize the tray and label it as the kit. Note the devices were provided sterile earlier but now the way they are packaged in different. We will be reperforming the sterilization validation for the new tray and package. But i wanted to confirm if this is a change that would require a special 510(k) or just internal documentation.

Any suggestions on how this change should me handled?

Thanks,
Hi,

In my opinion this would definitely require a special 510(k), as this is a substantial change in the technological characteristics of the product, and could definitely affect safety (if not done properly). This is also in line with the excellent explanation above from bclichten, according to which the older "add to file" has later become today's special 510(k). Perhaps you spoke to someone from the old school...

Cheers,
Ronen.
 
L

Laughing Pierre

#18
Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

Hi,

Coming to this thread late, BUT...

I've just had a request from FDA to "send an add-to-file to the cleared 510(k)" and have no idea how to do that. The request has come after we have told FDA that we have worked through all of the guidance and have determined that a new 510(k) of any variety) is not required.

The "new" device is a version of a cleared device which has been modified to significantly reduce the risks associated with it. We want to get the modified device listed with the original device so that there are no problems with it clearng customs.

Our communication from FDA seems vaery similar to that experienced by rakma. In the intervening period has anybody out there discoverred how to submit an add-to-file and what format it should take?
 

Ronen E

Problem Solver
Staff member
Moderator
#19
Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

The "new" device is a version of a cleared device which has been modified to significantly reduce the risks associated with it. We want to get the modified device listed with the original device so that there are no problems with it clearng customs.
Hi,

In my opinion, it all comes down to the nature of change. From the little info provided I gather that the intended use was not changed (or was it?), and so the special 510(k) decisive question is "was there a substantial change in the technological characteristics?". You state that your goal was to significantly reduce the risks associated with the device, but how was it done? If the technological change was substantial, then a special 510(k) is required. It doesn't matter if the change was an improvement or not; either way you have to clear it. Regarding the ambiguity of the "Add to file" terminology, I would have presented a direct question to the FDA if I was in a similar situation.

I'm not sure how all this relates to clearing customs, but I'm no USA customs expert anyway...

Cheers,
Ronen.
 
D

drewsky1

#20
Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

Our company would like to create/revise our SOP for Deciding when to submit 510k or not when an existing product may need a design change. WE call it a Regulatory Assessment document which is made to determine this and we keep on file. It is not a letter file but a regulatory assessment decision. Does anyone out there have an SOP like this in there company? What type of questions should be asked to the R&D, Mfr Depts that will be initiating the change?

Thanks
 
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