FDA releases new draft guidance on when to submit a 510(k) for device modification

Ronen E

Problem Solver
Staff member
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#1
Today the FDA released two draft guidance documents: “Deciding When to Submit a 510(k) for a Change to an Existing Device,” which applies to medical device changes broadly, and “Deciding When to Submit a 510(k) for a Software Change to an Existing Device,” which focuses on software-specific changes.

Medical device technology is constantly evolving, and not all changes made to existing devices require FDA’s review. These draft recommendations are intended to provide guiding principles to help manufacturers determine when an intended change to a legally marketed medical device subject to premarket notification (510(k)) requirements is significant enough to warrant FDA review, including major changes or modifications to the intended use that could significantly impact safety and effectiveness.

These draft guidance documents build on the process described in “Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1),” published January 10, 1997 and incorporates input from the FDA’s 2013 public meeting on 510(k) device modifications and comments received in response to the FDA’s Report to Congress on 510(k) device modifications. Updates in the draft guidance documents include clarifying key terms, explaining how to use risk assessment to evaluate whether or not a change requires a new 510(k), harmonization of flowcharts with the text of the guidance, examples of device changes that would or would not require a new 510(k), and recommendations for documenting decisions about whether or not to submit a new 510(k) for a device change.

When finalized, these guidance documents will supersede “Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1)” issued in 1997.
http://www.fda.gov/downloads/Medica...ivery&utm_medium=email&utm_source=govdelivery
 
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TWA - not the airline

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#2
Re: FDA releases new draft guidance on when to submit a 510(k) for device modificatio

If I remember correctly this is the second try; there had already been a draft which was withdrawn some time ago. Anyone already looked into this? Any nasty surprises?
 

Mark Meer

Trusted Information Resource
#3
Re: FDA releases new draft guidance on when to submit a 510(k) for device modificatio

...Anyone already looked into this? Any nasty surprises?
My first thoughts too! :lol:

I haven't looked into the new guidance yet, but it really says a lot about the relationship between the FDA and industry when our first question is "are there any nasty surprises?"...

Shame our first thought couldn't be "how is this better?". Ah well, such is the regulatory world we live in...
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Re: FDA releases new draft guidance on when to submit a 510(k) for device modificatio

My first thoughts too! :lol:

I haven't looked into the new guidance yet, but it really says a lot about the relationship between the FDA and industry when our first question is "are there any nasty surprises?"...

Shame our first thought couldn't be "how is this better?". Ah well, such is the regulatory world we live in...
As someone who's followed this over the years (to get proper context one must have been around since at least 2011), I strongly disagree. This saga was brought on mostly by industry and its lobbying. The initial FDA intention was to make the situation / process clearer and more transparent than the 1997 guidance made it for years, very much on account of industry cries. The 2011 draft was a step in the right direction, but then industry intervened because apparently it was perceived that the new guidelines would have resulted in more submissions (I thought it was reasonable and definitely better than the 1997 guidance in terms of clarity and transparency). FDA was forced to go through a lengthy legal / administrative process and I applaud their perseverance in that instance. I haven't scrutinised the result yet but given the extensive consultation I tend to believe that it is actually better or at the very least not worse.

"Nasty" and "surprises" are in the eyes of the beholder. The process was quite open and transparent in my opinion.

BTW, I have absolutely no affiliation with the FDA, and never had.
 

TWA - not the airline

Trusted Information Resource
#5
Re: FDA releases new draft guidance on when to submit a 510(k) for device modificatio

As someone who's followed this over the years (to get proper context one must have been around since at least 2011), I strongly disagree. This saga was brought on mostly by industry and its lobbying. The initial FDA intention was to make the situation / process clearer and more transparent than the 1997 guidance made it for years, very much on account of industry cries. The 2011 draft was a step in the right direction, but then industry intervened because apparently it was perceived that the new guidelines would have resulted in more submissions (I thought it was reasonable and definitely better than the 1997 guidance in terms of clarity and transparency). FDA was forced to go through a lengthy legal / administrative process and I applaud their perseverance in that instance. I haven't scrutinised the result yet but given the extensive consultation I tend to believe that it is actually better or at the very least not worse.

"Nasty" and "surprises" are in the eyes of the beholder. The process was quite open and transparent in my opinion.

BTW, I have absolutely no affiliation with the FDA, and never had.
Ronen, I stopped following the issue when the old draft was withdrawn. I fully agree that the 1997 guidance needs to be polished up and also that the draft version that was withdrawn actually wasn't a bad one. It is just that my experience in any field is that the second try is only better if you really messed up the first one, but typically much worse if the first one was already decent...
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Re: FDA releases new draft guidance on when to submit a 510(k) for device modificatio

I think the FDA had a tough one this time because they had contradicting forces to satisfy. Either way I think an updated guidance is better than an almost-20-years-old guidance.

Let's please not forget that the current one is a DRAFT guidance and the purpose of releasing it is obtaining FEEDBACK. If something seems wrong, now is the time to speak up.
 

Statistical Steven

Statistician
Staff member
Super Moderator
#7
Re: FDA releases new draft guidance on when to submit a 510(k) for device modificatio

First ask the question, why was there a need for the guidance? If I make a change to my already cleared device, it was a design change and NO 510(k) was needed. But then 13485:2015 comes along and design changes based on risk mitigation or risk reduction would make the device a different device, so it was confusing for device manufacturers if they needed to file a new 510(k) in the US when updating the EU filing. It is really nothing new and just means an updated 510(k) will be filed when updating the EU filing in my limited experience with this issue.
 

Ronen E

Problem Solver
Staff member
Moderator
#8
Re: FDA releases new draft guidance on when to submit a 510(k) for device modificatio

First ask the question, why was there a need for the guidance? If I make a change to my already cleared device, it was a design change and NO 510(k) was needed. But then 13485:2015 comes along and design changes based on risk mitigation or risk reduction would make the device a different device, so it was confusing for device manufacturers if they needed to file a new 510(k) in the US when updating the EU filing. It is really nothing new and just means an updated 510(k) will be filed when updating the EU filing in my limited experience with this issue.
:confused:

I don't think that's the issue. This kind of guidance has been around since 1997 and as far as I know has nothing to do with ISO 13485 or the EU regulations. The 1997 guidance wasn't that bad, it just had some shortcomings in the grey areas. The current update has been long needed and has in fact been in the making since before 2011 (definitely before the current update of ISO 13485).
 

Marcelo

Inactive Registered Visitor
#9
Re: FDA releases new draft guidance on when to submit a 510(k) for device modificatio

First ask the question, why was there a need for the guidance? If I make a change to my already cleared device, it was a design change and NO 510(k) was needed. But then 13485:2015 comes along and design changes based on risk mitigation or risk reduction would make the device a different device, so it was confusing for device manufacturers if they needed to file a new 510(k) in the US when updating the EU filing. It is really nothing new and just means an updated 510(k) will be filed when updating the EU filing in my limited experience with this issue.
This has nothing to do with ISO 13845. Also, risk management is already included in the 2003 edition of 13485 (we did expand and clarified stuff in the 2016 edition, but design changes related to risk management was not one of the things included as it was already there).
 
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