Deciding When to Submit a 510(k) for a Change to an Existing Device

shimonv

Trusted Information Resource
#1
Hi Everyone,
Some of you may know this draft guidance:

"Guidance for Industry and FDA Staff - 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device"

It is interned to replace the current version (from 1997).

Does anyone know when will it become effective? and which parts of it?

If implemented "as is" it will make our lives more difficult and, in may opinion, won't make medical devices more safe & effective to use...

Thanks!
Shimon
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
Hi Everyone,
Some of you may know this draft guidance:

"Guidance for Industry and FDA Staff - 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device"

It is interned to replace the current version (from 1997).

Does anyone know when will it become effective? and which parts of it?

If implemented "as is" it will make our lives more difficult and, in may opinion, won't make medical devices more safe & effective to use...

Thanks!
Shimon
Hi,

As stated in: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm265274.htm :

Although the notice of availability for this Draft Guidance stated that the comment period would close on October 25, 2011, FDA will continue to accept comments until the deadline specified in the forthcoming notice extending the comment period. FDA will post the notice announcing the extension of the comment period when it becomes available.
Obviously the guidance will not take effect while it's open for comment. I understand the above as "this draft is open for comment until further notice", and thus will not take effect until further notice...

Cheers,
Ronen.
 
M

MIREGMGR

#3
Obviously the guidance will not take effect while it's open for comment.
I've had direct experience with US FDA to the effect that guidances are applied and effectively enforced as soon as they are published, even though they are in draft status. FDA has a number of guidances that have been in draft status for years, and for which there is no active program for further development due to resource prioritization.

Citations of course are always in regard to the US Code, not to a guidance, so FDA's application of a guidance in shaping inspection judgements and filing reviews may only be apparent by inquiry or discussion.

My understanding of CDRH's operational approach is that inspectors and examiners are expected to regard FDA's latest published version of every guidance as definitive unless there has been internal notice that a revision is planned. A majority of guidances that have comment periods upon initial publication aren't revised.
 

shimonv

Trusted Information Resource
#4
MIREGMGR,
Thank you for the valuable input.
My followup question is: what are we to do with regards to this guidance document? Can I simply ignore it and and to internal filing based on the current guidance document. If a field auditor comes we can explain that we are using the current guidance to interpret the meaning of "significant change". I'd be surprised if we get a citation based on a principles from the new draft document which is not effective!
But than again, we are not in a position to argue for federal agent...

Thanks,
Shimon
 
M

MIREGMGR

#5
Sometimes when I have a question about what guidance is effective, or about an apparent conflict between an older final guidance and a newer draft guidance, I call FDA DSMICA and ask.

The other option is just to assume that the latest published information is definitive, even if it's stated to be a draft. Usually that's what I do.
 

Ronen E

Problem Solver
Staff member
Moderator
#7
I've had direct experience with US FDA to the effect that guidances are applied and effectively enforced as soon as they are published, even though they are in draft status. FDA has a number of guidances that have been in draft status for years, and for which there is no active program for further development due to resource prioritization.

Citations of course are always in regard to the US Code, not to a guidance, so FDA's application of a guidance in shaping inspection judgements and filing reviews may only be apparent by inquiry or discussion.

My understanding of CDRH's operational approach is that inspectors and examiners are expected to regard FDA's latest published version of every guidance as definitive unless there has been internal notice that a revision is planned. A majority of guidances that have comment periods upon initial publication aren't revised.
OK, perhaps my comment was a bit naive, so I take it back. Thanks for putting things in the right perspective.

A question then: What is the meaning, in this context, of the term "draft"? If they issue guidance and mostly start operating upon it right away, then this term is almost meaningless to me. Every published guidance should be regarded as effective and final until further notice, regardless of its "titled" status, shouldn't it?
 

shimonv

Trusted Information Resource
#8
Hello Ronen,
To answer your question - the best thing would be to call FDA and ask.
If I try to round up all the information available in this thread I'd say this:

A guidance document is a all that it is: a guidance document.
It's not likely to get a citation just because we didn't consider the content of a new draft guidance document; with an effective document we'd get one for sure...

If a field inspector comes, he will challenge your decision based on all the information available to him, including a draft guidance.
If you didn't address the guiding questions laid-out in this draft version as part of your rational for letter-to-file, you could get a citation if he concludes that the change could significantly affect safety and effectiveness. If you don't prepare in advance you'd be more vulnerable. The citation would be for none-compliance with CFR code.

This is taken from the new draft document:
"If a manufacturer determines that its device modification(s) could not
significantly affect safety or effectiveness and therefore decides not to submit a new 510(k), it should document the basis for concluding that it does not require a 510(k). Manufacturers should scientifically justify their conclusions that modifications, individually and collectively, could not affect safety or effectiveness.
A copy of this documentation should be maintained. It is recommended that manufacturers answer each question below to satisfy basic
Quality System requirements for documenting device modifications.
See 21 CFR 820.30 and 820.70(b). "

Therefore I conclude that a letter to file must answer the guiding questions laid out in this document, otherwise he could get in trouble.
Once the document becomes effective he will for sure get in trouble.

Does anyone agree or think otherwise?



Shimon
 
M

MIREGMGR

#9
What is the meaning, in this context, of the term "draft"?
My perhaps-incomplete historical understanding is that US FDA in earlier times intended to have a draft-not-yet-effective, period-for-comments, consensus-final-version guidance development system. In theory that's how it works now.

The US governmental system for bureaucratic review and approval of rules and regulations being such that it is, though, as I understand it the operational people at FDA who are tasked with actually accomplishing a safe and effective medical device environment and who create the first drafts of guidances began to advise inspectors and examiners to regard drafts as representing where the rules were expected to go, during the lengthy period of review.

That then evolved over time, as the review process proved to be practically endless, into an effective abandonment of getting official approval of drafts, and a hardening of the "advice" to inspectors and examiners into "direction".

It's a much more effective system, albeit dictatorial, i.e. it's totally dependent on the FDA's operational people being on exactly the right wavelength to demand just the right amount of rigor.
 

Wes Bucey

Quite Involved in Discussions
#10
FDA and FAA are similar in that they require notice of changes in products under their purview. The decision point is what is the extent of change which triggers resubmission, perhaps even retesting for safety and efficacy. It is no joke when one of these regulatory bodies comes after a manufacturer becausethey think the manufacturer was trying to "put one over on" the agency, possibly jeopardizing end users, just to avoid the time, trouble, and cost of dealing with a little bureaucratic red tape.

My risk assessment when dealing with either FDA or FAA was always the downside that the agency could arbitrarily shut me down (cutting off income, but not expenses) while I dealt with a glacial bureaucracy.

We have an icon for just this situation: :ca:

Look at it this way - a phone call today is a lot cheaper than most of the alternates. Try to get written verification of the verbal opinion. Don't forget that it isn't only a random FDA employee who may get a bee in his bonnet about your documentation - competitors, disaffected employees, and others have been known to "drop a dime" to make anonymous complaints (sometimes not so anonymous) in hopes of getting a share in any penalties levied against your organization. I'm aware of an organization in Florida that has made a large fortune in such fees in a number of cases with the FDA (not strictly on medical devices, of course.)
 
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