Hi Rashmi,
You have a FSCA (recall), don't try to dance around it with a change to a 510(k), whether a letter to file or a "significant change". What would you propose the change to be, to supply a replacement part separate from your kit for the defective part in your kit? A notification to the clinician to not use the defective part is in itself a FSCA. You cannot make the user responsible for detecting that your firm supplied a defective part. Delay of treatment or failure of intent to treat are health hazards, even if the user will find this prior to commencing the procedure. Keep in mind that a recall from the FDA standpoint can be a number of actions if justifiable, including supplying the replacement rather than physically recalling all of the distributed kits. Your risk analysis will play into this, and will need to have a medical officer sign off on a health hazard analysis. However, if FDA agrees with this action, it will almost certainly be accepted only for product already distributed to the end user, with the expectation that product still within your distribution chain will be recovered and either destroyed or reworked. I suggest you put together your recall package and speak to FDA about future actions. If you aren't up front about this you may find yourself with a Warning Letter.
James
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James Bonds J.D.
Director Regulatory Affairs
Atlanta GA
United States
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Original Message:
Sent: 21-Aug-2019 08:17
From: Rashmi Pillay
Subject: Significant change
Hi James,
Thanks for your response.
The product cannot be used with the faulty part , that is the user will find this before the start of the procedure and will not proceed. Hence from the risk analysis point of view, will have minimum risk / no risk (actions which will fall under 21 CFR 806.1) The product has only been supplied to US and not in EU yet. Hence the question of significant change rather than a FSCA.
Thanks & Regards,
Rashmi Pillay
Regulatory Affairs Associate
Ellex
3-4 Second Avenue
Mawson Lakes SA, 5095
T + 61 8 7074 8105
E rpillay@ellex.com
W ellex.com
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Original Message------
You are FSCA territory. The best course of action would probably be to recall the non-conforming kits and rework. A notification that you explain the issue and provide acceptable parts would require a thorough risk analysis with the assumption that a user would not read the notification to discard the kit parts and use them regardless of the provision of replacement. A very risky and non-justifiable pathway, in my opinion. The only way this would pass regulatory muster is if there is minimal risk and there are no alternative products in the marketplace, and even so would require full notification and buy-in from regulatory authorities.
Your message seems to presume that there are no US FDA ramifications since the replacement component has a 510(k) and that your major concern with the EU is if the addition of a replacement part to your kit is a significant change affecting your Technical File that has to be reported to your NB. This thought pathway is misguided, as you have apparently marketed adulterated (US) or non-compliant (EU) product and the FSCA is the appropriate pathway in either case. This is not a case of modification of the DMR to include a replacement part and move along without recognizing the underlying issue. Remember that regulatory authorities care not about your commercial demand if alternatives are available in the marketplace.
James
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James Bonds J.D.
Director Regulatory Affairs
Atlanta GA
United States
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