Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi All, 

Can a same applicant submit two 510(k) submissions a month apart for independent, isolated changes, does FDA handle parallel submissions. Does anyone have any experience with submitting 510k for the same device in parallel, for example one for solely SW change while the other for the HW and both are part of same system cleared under same original 510k but the changes are independent of each other. Does FDA handle multiple submissions from the same applicant that are under review simultaneously. 

Appreciate some guidance on this. 

Hello Anon,

This is highly frowned upon.  While there is nothing stating this can not be done, the 510(k) application process is not a "parallel" process consideration of changes made to a finished medical device.  The problem is if a 510(k) is submitted for software changes and a separate 510(k) is submitted for hardware changes, then they have to cross reference all of the activities which is more time consuming.  It would be recommended to either submit one (1) 510(k) submission for everything all together in the system.  Or submit the changes in sequence as example, submit hardware changes in one application, once cleared, immediately submit the following application for the software changes.  However, personally I would not recommend this either because the FDA reviewer needs to look at things in totality.  It would be quite challenging to submit changes for hardware and software separately from a review perspective.  There are of course circumstances where this could be done, such as, if the system had an "App" which was independent and being changed.  So the hardware/software of the electromechanical device could be submitted in one application and then at a later date submit changes to the App which are still part of the system.  Recommend seeking some further expert advice on this as could significantly delay submission processing.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 26-Mar-2024 16:47
From: Anonymous Member
Subject: 510k parallel submission for same device? FDA review multiple submissions for same device?

This message was posted by a user wishing to remain anonymous

Hi All, 

Can a same applicant submit two 510(k) submissions a month apart for independent, isolated changes, does FDA handle parallel submissions. Does anyone have any experience with submitting 510k for the same device in parallel, for example one for solely SW change while the other for the HW and both are part of same system cleared under same original 510k but the changes are independent of each other. Does FDA handle multiple submissions from the same applicant that are under review simultaneously. 

Appreciate some guidance on this. 

This message was posted by a user wishing to remain anonymous

Hi Richard, @Richard Vincins   

Thank you so much for your response, very much appreciated! 

Sorry my question was a bit vague and said HW changes. Hence, providing a little more details - The changes that we are making are to the reprocessing of the instruments that are used with the System. Basically the submission is to qualify new AER for the cleaning of the instruments.  These instruments are used with the electro mechanical system which has SW in it but then system by itself is not sterile or does not require any kind of reprocessing. Hence the thought-process was - these changes can be considered independent and can be submitted as separate 510ks in parallel one for reprocessing of instruments and another for SW changes. But then all these (System with SW and instruments and accessories) are a part of same system cleared under same original 510k. 

Original Message:
Sent: 01-Apr-2024 12:40
From: Richard Vincins
Subject: 510k parallel submission for same device? FDA review multiple submissions for same device?

Hello Anon,

This is highly frowned upon.  While there is nothing stating this can not be done, the 510(k) application process is not a "parallel" process consideration of changes made to a finished medical device.  The problem is if a 510(k) is submitted for software changes and a separate 510(k) is submitted for hardware changes, then they have to cross reference all of the activities which is more time consuming.  It would be recommended to either submit one (1) 510(k) submission for everything all together in the system.  Or submit the changes in sequence as example, submit hardware changes in one application, once cleared, immediately submit the following application for the software changes.  However, personally I would not recommend this either because the FDA reviewer needs to look at things in totality.  It would be quite challenging to submit changes for hardware and software separately from a review perspective.  There are of course circumstances where this could be done, such as, if the system had an "App" which was independent and being changed.  So the hardware/software of the electromechanical device could be submitted in one application and then at a later date submit changes to the App which are still part of the system.  Recommend seeking some further expert advice on this as could significantly delay submission processing.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA

Original Message:
Sent: 26-Mar-2024 16:47
From: Anonymous Member
Subject: 510k parallel submission for same device? FDA review multiple submissions for same device?

This message was posted by a user wishing to remain anonymous

Hi All, 

Can a same applicant submit two 510(k) submissions a month apart for independent, isolated changes, does FDA handle parallel submissions. Does anyone have any experience with submitting 510k for the same device in parallel, for example one for solely SW change while the other for the HW and both are part of same system cleared under same original 510k but the changes are independent of each other. Does FDA handle multiple submissions from the same applicant that are under review simultaneously. 

Appreciate some guidance on this.