Class II Medical Device Design Control Non Conformance

M

melissa87

#1
Hi,

I have the following question regarding classII medical device. I recently joined this company earlier this year.

My company is a startup and did not know anything about QMS. The engineers designed and developed the device in the period 2005 to 2011 and with a help of FDA consultant wrote 510K and submit it to FDA. FDA approved the device in 2012.

They also got 5 prototypes built too. FDA came to investigate us earlier this year but we did not sell any and never went to production stage so FDA said that since you are in verification and validation stage so there is nothing to investigate. We will come later.

Now my boss wants to go to production stage but design control does not exist. The 510k that engineers wrote do include

1. verification and validation documents
2. Test Results
3. Design Input
4. Design outputs
etc.

But there was no Design Control SOP or any other SOP exsisted at that time. Now my boss wants to go to prodcution stage asap.

I have all the documentation regarding production stage like DMR, FMEA , Drawings, CAPA SOP, Supplier Control SOP, Document control SOP, etc.

But the Design Control needs to be done and formally put in place and evolved. My question is

1. If I do Design Control now, how would FDA will view it at the time of the next Audit because it never exsisted when it should exsisted and I might not be done with it soon and my boss wants to go to production. I might get all done during production.
2. Can I initiate Design Control work using a CAPA( Corrective Action)?

Please comment!

Melissa
 
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mihzago

Trusted Information Resource
#3
Re: Design Control Non Conformance

The FDA will definitely take an issue with lack of documentation and or procedures; based on what you have and what you remediate will depend the type of action the FDA takes during the next audit - from 483, to warning letter, to seizure of the product.

You should definitely make up all the documentation, but that will also require repeating many of the activities e.g. V&V, or some of the reviews. Retrospective documentation is tricky.
Opening a CAPA may be a good way to show the auditor that you recognized the problem and approach it in a planned, systematic matter with full support of the management.

The CAPA should include creation of project records and establishment of procedures (going forward). Don't forget about training.

There are many aspects of remediation, but hope this helps at a high level.
 
T

treesei

#4
Re: Design Control Non Conformance

I agree with mihzago that a CAPA would be a good idea especially if you are not sure if you can complete all design control documentation etc before the FDA comes again. Also, by having a CAPA, it might be easier to get support from other teams such as engineering. Don't panic. Sit down and start to compile the documents you have into a DHF. You may find you have more that you thought. Do as much as you can before the production phase starts. You can do it.:)
 

Weiner Dog

Med Device Consultant
#5
Re: Design Control Non Conformance

Hi Melissa,

if your company does not have an established and maintained proper quality system, FDA will definitely issue a Warning Letter during the level II QSIT inspection. If deviations are not caught and corrected via your internal audit and CAPA systems and FDA returns for a level III 'for cause' inspection, additional sanctions will occur!!!

I have worked for the FDA for over 21 years and now am a medical device regulatory compliance consultant. I have some template design control (and other QSR subsystem) procedures that you can modify & can assist with design controls and other QSR elements too. Additionally, I conduct proper internal and supplier audits, and give QSR, design controls, CAPA, et al training too.

George
 
M

melissa87

#6
Re: Design Control Non Conformance

Hi Thanks very much for your replies. If my boss backs off from production for a month then I can pull it off.
Melissa
 
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