Regulatory Open Forum

Since the beginning of 2013 the FDA starts proposing de novo route as alternative for class II devices that could have been cleared in the past through 510k route.
Please share your experience with timeline of the two phases of the de novo pathway clearances.

-------------------------------------------
Yoram Levy
General Manager
QSite
Binyamina
Israel
-------------------------------------------

Mr. Levy:

I am not sure what you are referring to relative to the FDA starting "proposing" the de novo route as of 2013 for Class II devices because the de novo route only applies to devices that are automatically placed into Class III due to the lack of a predicate device allowing for a 510(k).  This has been the law since 1997 when the de novo route was enacted as part of the Food & Drug Administration Modernization Act (FDAMA).

There have been a couple recent developments impacting the de novo process.  First, in October 2011, FDA published a draft guidance on the de novo process.  Second, in July 2012, as part of the Food & Drug Administration Safety & Innovation Act (FDASIA), Congress eliminated an unwieldy procedural requirement that had required that, before anyone could seek approval of a de novo petition, they first had to submit a 510(k) and have it denied as not substantially equivalent (NsE).  After FDASIA, this step is no longer needed.  However, if one follows the October 2011 guidance carefully, the agency has created a process for de novo petitions that is quite challenging even without having to first file a 510(k) and get an NSE letter.

I gave a presentation on the de novo process about a year ago.  Yyou can access the slides for that presentation at my personal website at http://www.fdacounsel.com/files/FX_Conferences_--_de_novo_--_20120215.pdf. 

On my website, you also will find a matrix of all the de novo petitions approved as of the time of my 2012 presentation.  http://www.fdacounsel.com/files/De_Novo_Decisions_--_1998_to_2012.xlsx  I think you will find the matrix quite helpful as it also includes links to key documents relating to the 70 petitions.

If you have any other questions on the de novo process, please feel free to contact me directly. 

Best regards,

Michael A. Swit


______________________________________________
Michael A. Swit, Esq.
Special Counsel, FDA Law Practice
Duane Morris LLP
750 B Street, Suite 2900
San Diego, CA 92101-4681
P: +1 619 744 2215
F: +1 619 923 2648
C +1 760 815 4762
maswit@duanemorris.com

Note: all postings by me on this forum represent my personal views and are not necessarily those of my clients or my law firm. Further, my comments are not intended as legal advice but as the sharing of general knowledge and do not create an attorney-client relationship with any reader.

Please follow me on LinkedIN and Twitter:
http://www.linkedin.com/in/michaelswit
https://twitter.com/FDACounsel

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Original Message:
Sent: 02-16-2013 02:13
From: Yoram Levy
Subject: FDA de novo route

Since the beginning of 2013 the FDA starts proposing de novo route as alternative for class II devices that could have been cleared in the past through 510k route.
Please share your experience with timeline of the two phases of the de novo pathway clearances.

-------------------------------------------
Yoram Levy
General Manager
QSite
Binyamina
Israel
-------------------------------------------

Thank you Michael,
It is quite helpfull.
Yoram

-------------------------------------------
Yoram Levy
General Manager
QSite
Binyamina
Israel
-------------------------------------------






Original Message:
Sent: 02-17-2013 22:41
From: Michael Swit
Subject: FDA de novo route

Mr. Levy:

I am not sure what you are referring to relative to the FDA starting "proposing" the de novo route as of 2013 for Class II devices because the de novo route only applies to devices that are automatically placed into Class III due to the lack of a predicate device allowing for a 510(k).  This has been the law since 1997 when the de novo route was enacted as part of the Food & Drug Administration Modernization Act (FDAMA).

There have been a couple recent developments impacting the de novo process.  First, in October 2011, FDA published a draft guidance on the de novo process.  Second, in July 2012, as part of the Food & Drug Administration Safety & Innovation Act (FDASIA), Congress eliminated an unwieldy procedural requirement that had required that, before anyone could seek approval of a de novo petition, they first had to submit a 510(k) and have it denied as not substantially equivalent (NsE).  After FDASIA, this step is no longer needed.  However, if one follows the October 2011 guidance carefully, the agency has created a process for de novo petitions that is quite challenging even without having to first file a 510(k) and get an NSE letter.

I gave a presentation on the de novo process about a year ago.  Yyou can access the slides for that presentation at my personal website at http://www.fdacounsel.com/files/FX_Conferences_--_de_novo_--_20120215.pdf. 

On my website, you also will find a matrix of all the de novo petitions approved as of the time of my 2012 presentation.  http://www.fdacounsel.com/files/De_Novo_Decisions_--_1998_to_2012.xlsx  I think you will find the matrix quite helpful as it also includes links to key documents relating to the 70 petitions.

If you have any other questions on the de novo process, please feel free to contact me directly. 

Best regards,

Michael A. Swit


______________________________________________
Michael A. Swit, Esq.
Special Counsel, FDA Law Practice
Duane Morris LLP
750 B Street, Suite 2900
San Diego, CA 92101-4681
P: +1 619 744 2215
F: +1 619 923 2648
C +1 760 815 4762
maswit@duanemorris.com

Note: all postings by me on this forum represent my personal views and are not necessarily those of my clients or my law firm. Further, my comments are not intended as legal advice but as the sharing of general knowledge and do not create an attorney-client relationship with any reader.

Please follow me on LinkedIN and Twitter:
http://www.linkedin.com/in/michaelswit
https://twitter.com/FDACounsel

-------------------------------------------






Original Message:
Sent: 02-16-2013 02:13
From: Yoram Levy
Subject: FDA de novo route

Since the beginning of 2013 the FDA starts proposing de novo route as alternative for class II devices that could have been cleared in the past through 510k route.
Please share your experience with timeline of the two phases of the de novo pathway clearances.

-------------------------------------------
Yoram Levy
General Manager
QSite
Binyamina
Israel
-------------------------------------------

As a follow up to Michael Swit's information - I have been working with a client in the pre-submission phase of a product for which we hope to acheive a de novo clearance.  While the law has been changed, the IVD group we are working with would not provide a definitive answer to the question prior to the issuance of new guidance for de novo submissions.   If you are ready to make your submission prior to the guidance, you'll just have to take your best show blending the prior guidance with the draft "benefit-risk" guidance and data from the appropriate appendices  (C and H) in ISO 14971 to make a case for Class II. 

While you can submit a classification petition, my feeling is that a response would be delayed until the new guidance is available.

Good luck!

Glen

-------------------------------------------
Glen Freiberg RAC
President
Rancho Santa Fe CA
United States
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Original Message:
Sent: 02-17-2013 22:41
From: Michael Swit
Subject: FDA de novo route

Mr. Levy:

I am not sure what you are referring to relative to the FDA starting "proposing" the de novo route as of 2013 for Class II devices because the de novo route only applies to devices that are automatically placed into Class III due to the lack of a predicate device allowing for a 510(k).  This has been the law since 1997 when the de novo route was enacted as part of the Food & Drug Administration Modernization Act (FDAMA).

There have been a couple recent developments impacting the de novo process.  First, in October 2011, FDA published a draft guidance on the de novo process.  Second, in July 2012, as part of the Food & Drug Administration Safety & Innovation Act (FDASIA), Congress eliminated an unwieldy procedural requirement that had required that, before anyone could seek approval of a de novo petition, they first had to submit a 510(k) and have it denied as not substantially equivalent (NsE).  After FDASIA, this step is no longer needed.  However, if one follows the October 2011 guidance carefully, the agency has created a process for de novo petitions that is quite challenging even without having to first file a 510(k) and get an NSE letter.

I gave a presentation on the de novo process about a year ago.  Yyou can access the slides for that presentation at my personal website at http://www.fdacounsel.com/files/FX_Conferences_--_de_novo_--_20120215.pdf. 

On my website, you also will find a matrix of all the de novo petitions approved as of the time of my 2012 presentation.  http://www.fdacounsel.com/files/De_Novo_Decisions_--_1998_to_2012.xlsx  I think you will find the matrix quite helpful as it also includes links to key documents relating to the 70 petitions.

If you have any other questions on the de novo process, please feel free to contact me directly. 

Best regards,

Michael A. Swit


______________________________________________
Michael A. Swit, Esq.
Special Counsel, FDA Law Practice
Duane Morris LLP
750 B Street, Suite 2900
San Diego, CA 92101-4681
P: +1 619 744 2215
F: +1 619 923 2648
C +1 760 815 4762
maswit@duanemorris.com

Note: all postings by me on this forum represent my personal views and are not necessarily those of my clients or my law firm. Further, my comments are not intended as legal advice but as the sharing of general knowledge and do not create an attorney-client relationship with any reader.

Please follow me on LinkedIN and Twitter:
http://www.linkedin.com/in/michaelswit
https://twitter.com/FDACounsel

-------------------------------------------






Original Message:
Sent: 02-16-2013 02:13
From: Yoram Levy
Subject: FDA de novo route

Since the beginning of 2013 the FDA starts proposing de novo route as alternative for class II devices that could have been cleared in the past through 510k route.
Please share your experience with timeline of the two phases of the de novo pathway clearances.

-------------------------------------------
Yoram Levy
General Manager
QSite
Binyamina
Israel
-------------------------------------------