Retrospective DHF for an old non-registered device

K

Krthna

#1
Hello!

My backstory is a that we're a very small medical device manufacturer that manufactures (what will be) Class I and II devices (very low-risk), and I have no experience in the Quality Field at all. We haven't had a documented quality system and the required FDA files (DMRs, DHRs, and DHFs).

We're putting those together and it wouldn't be possible without this forum. So much of the Quality Industry is implicit knowledge and experience-based and this forum really helps! So, thank you!!!

I have two questions-

The FDA has us on its radar and we have a warning letter. We are going to be applying for 510(k)s and DeNovos (or PreDeNovos) in the 4th quarter this year.

Some of our products have been on the market for a long time.

We don't have everything that went into the design back then and we do have a number of changes that have occurred since that first product(s) went on sale.

1. The retrospective DHF - does anyone have any advice on where to begin?
Should we begin with the current iteration of the device (fresh start) or should we attempt to piece it together to the best of our ability?
In the former's case - should the primary design input be the older design? Do we still need a planning stage and documentation?

2. We're a small (tiny) company and changes are very rapid in terms of design and process. Once we have a DHF in place (and the DMR), and we apply for and register the product with the FDA, how do we incorporate these changes (assuming we do the documented input, review, output process) before we have to file changes before the FDA?
Should we attempt having more static products and processes after a 510(k)?
For example, we make minor modifications like adding digital output, or an extra input port; or assembly procedure may change based on who's doing what and what they learn on the job.
I understand that all the little changes eventually add up, but it's, sort of like, company culture (we're 3 people strong here) to change things ever so often.

I hope the questions make sense. Any help will be much appreciated!

Regards,
Krthna.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Oh no, what a mess...

First thing first:

If you have a warning letter from the FDA, that should be top priority.
(a) understand what the letter actually says (and what it doesn't).
(b) respond in a timely manner (15 business days fom receiving the letter), and to-the-point.
(c) prepare a written work plan to implement corrective actions (rather than just corrections), to eliminate all concerns expressed in the letter. Share with the FDA (if you can, in your initial response).
(d) implement the plan and gather evidence, including for effectiveness of corrective actions (= that root causes have been eliminated), and keep the FDA posted.

I really hope you don't intend to continue "business as usual" until Q4. Selling medical devices without proper regulatory clearance is a serious offence. If you don't have your devices on the market since 1976 or earlier (pre-amendments) then having them already on the market doesn't provide any concession; on the contrary.

Second, sort out and document your medical devices scope, and ascertain the classification of each. Class I requirements may be far lesser than class II (BTW, class II is usually referred to as medium risk; the risk as you perceive it has very little to do with regulatory obligations). For instance, many class I devices are exempt from 510k submission and Design Controls (meaning, they don't require a DHF at all). Once you have the ProCodes (FDA's 3-letter code for a specific device type) for each and every medical device you intend to market, you will be able to tell exactly what requirements apply to each. There could be a big difference.

Third, if you make class II devices, you most likely need a QMS compliant with 21 CFR part 820 ("QSR"). In creating one, you will address issues such as Design Control (including coverage of DHF etc.) and Change Control, among many others. You could start here: http://www.fda.gov/medicaldevices/d...medicaldevicequalitysystemsmanual/default.htm

Regarding the retro-DHF: You could go as if you are just introducing a new device to the market, if you made sure that there are no older version on the market (including in the distribution channels). If this is impossible, the DHF's scope would have to include any version that will be left out there. Wherever you begin, start with a new page and follow through the guidance on Design Control (820.30). Don't skip anything - planning, inputs etc. - as awkward as it may feel. If you absolutely can't retrieve or fabricate a certain piece, explain in detail and try to justify. Many times when one tries to justify in detail why something is impossible, they actually realize that a way exists to achieve the same...

...changes are very rapid in terms of design and process.
As a medical devices manufacturer, this is a privilege you will mostly have to give up.

Should we attempt having more static products and processes after a 510(k)?
Yes, definitely.

Once you will have a part-820-compliant Change Control SOP, you will have to follow it for every change. Doesn't necessarily mean that all changes - big or small - are handled at the same level; the SOP should provide decision making tools for keeping controls commensurate with change characteristics. These would also address the question of "should we notify / resubmit to the FDA?".

If your company is too small / lacks regulatory knowledge and experience, perhaps you better hire someone to help you with that. When a company gets a Warning Letter, it's typically a sign they need outside help, IMHO.

Cheers,
Ronen.
 
Last edited:
K

Krthna

#3
Thank you Ronen! That was a very informative reply!

Our problem is that we have no Substantially Equivalent predicate devices and applicable Procodes; the lowered requirements won't work, I think.

Mostly, we sold our products to researchers until recently, when our "rapid design changes" :) allowed us to begin selling to a broader market.

But we will persevere!
 

Ronen E

Problem Solver
Staff member
Moderator
#4
My pleasure.

...Mostly, we sold our products to researchers until recently...
Just to clarify, it doesn't really matter. The only thing that matters is what they are used for (as long as this is in line with your expressed intentions, not against them). If those researchers use them for clinical purposes (either on humans or other animals) they are likely to be deemed Medical Devices.

A device is:

"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

- recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals,

and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."
http://www.fda.gov/medicaldevices/d...nce/overview/classifyyourdevice/ucm051512.htm

Cheers,
Ronen.
 
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