Regulatory Open Forum

Hey RAPS!

So, this document [New Guidance] supersedes the "Refuse to Accept Policy for 510(k)s" issued August 4, 2015. 

Go ahead and download your copy for review ... and please share your review notes/comments ... we learn best from each other and through our network, so let us know how this new guidance might impact you.

Thanks.


------------------------------
John Beasley RAC
Founder and Senior Consultant
3M
Henderson NV
United States
------------------------------

Original Message------

Hey RAPS!

So, this document [New Guidance] supersedes the "Refuse to Accept Policy for 510(k)s" issued August 4, 2015. 

Go ahead and download your copy for review ... and please share your review notes/comments ... we learn best from each other and through our network, so let us know how this new guidance might impact you.

Thanks.


------------------------------
John Beasley RAC
Founder and Senior Consultant
3M
Henderson NV
United States
------------------------------

Original Message------

Sorry for my "signature" ... the new RAPS website created a signature and put a former employer ... 3M ... by default.  I will definitely need to review this ... the correct signature is shown here:

John Beasley, RAC (US)
Founding Member and Senior Consultant
MedTech Review, LLC
www.medtechreview.com
www.linkedin.com/in/medtechreview





257 Garnet Garden Street
Henderson, NV 89015

USA:  +1 612-889-5168
SKYPE:   medtechreview

Definitely a good document to read, digest, and follow if you are working on 510(k)s.  In the past, I had used the FDA's own checklist during our technical review (peer review) of 510(k) submission as the last step prior to be submitted which worked really well.  We went from around receiving 70% RTA down to less than 20%.  This was also supported not only following the checklist, but also understanding the needs and expectations of FDA reviewers.  It is a must to follow !  Don't let your company waste time or have to tell your CEO that the 510(k) is delayed because you didn't look at this document !

------------------------------
Richard Vincins RAC
Vice President Regulatory Affairs
------------------------------

Original Message:
Sent: 31-Jan-2018 13:24
From: John Beasley
Subject: Refuse to Accept

Hey RAPS!

So, this document [New Guidance] supersedes the "Refuse to Accept Policy for 510(k)s" issued August 4, 2015.

Go ahead and download your copy for review ... and please share your review notes/comments ... we learn best from each other and through our network, so let us know how this new guidance might impact you.

Thanks.


------------------------------
John Beasley RAC
Founder and Senior Consultant
3M
Henderson NV
United States
------------------------------

Thank you for the update and notification of this new guidance.  I will read and provide feedback shortly.  I have a somewhat similar question with regards to the checklist and what others are doing.  We have always historically filled out the checklist and submitted it with the applications, however I note that it is "optional".  What do others do and why? Does anyone routinely NOT provide a filled checklist?  Thanks.

------------------------------
Daniel Petersen
RA Specialist
Draper UT
United States
------------------------------

Original Message:
Sent: 01-Feb-2018 04:54
From: Richard Vincins
Subject: Refuse to Accept

Definitely a good document to read, digest, and follow if you are working on 510(k)s.  In the past, I had used the FDA's own checklist during our technical review (peer review) of 510(k) submission as the last step prior to be submitted which worked really well.  We went from around receiving 70% RTA down to less than 20%.  This was also supported not only following the checklist, but also understanding the needs and expectations of FDA reviewers.  It is a must to follow !  Don't let your company waste time or have to tell your CEO that the 510(k) is delayed because you didn't look at this document !

------------------------------
Richard Vincins RAC
Vice President Regulatory Affairs

Original Message:
Sent: 31-Jan-2018 13:24
From: John Beasley
Subject: Refuse to Accept

Hey RAPS!

So, this document [New Guidance] supersedes the "Refuse to Accept Policy for 510(k)s" issued August 4, 2015.

Go ahead and download your copy for review ... and please share your review notes/comments ... we learn best from each other and through our network, so let us know how this new guidance might impact you.

Thanks.


------------------------------
John Beasley RAC
Founder and Senior Consultant
3M
Henderson NV
United States
------------------------------

We always provide the completed checklist.

First we use it internally during peer review to make sure everything is there (and can be found) and then provide it in the submission as we have just created an unambiguous mapping to essential submission content in a format FDA is familiar with. It significantly decreases any confusion between FDA and the Sponsor on what the Sponsor has provided to satisfy each RTA requirement.

------------------------------
Michael Petrini RAC
Manager, Regulatory Affairs
Lakewood CO
United States
------------------------------

Original Message:
Sent: 02-Feb-2018 12:00
From: Daniel Petersen
Subject: Refuse to Accept

Thank you for the update and notification of this new guidance.  I will read and provide feedback shortly.  I have a somewhat similar question with regards to the checklist and what others are doing.  We have always historically filled out the checklist and submitted it with the applications, however I note that it is "optional".  What do others do and why? Does anyone routinely NOT provide a filled checklist?  Thanks.

------------------------------
Daniel Petersen
RA Specialist
Draper UT
United States

Original Message:
Sent: 01-Feb-2018 04:54
From: Richard Vincins
Subject: Refuse to Accept

Definitely a good document to read, digest, and follow if you are working on 510(k)s.  In the past, I had used the FDA's own checklist during our technical review (peer review) of 510(k) submission as the last step prior to be submitted which worked really well.  We went from around receiving 70% RTA down to less than 20%.  This was also supported not only following the checklist, but also understanding the needs and expectations of FDA reviewers.  It is a must to follow !  Don't let your company waste time or have to tell your CEO that the 510(k) is delayed because you didn't look at this document !

------------------------------
Richard Vincins RAC
Vice President Regulatory Affairs

Original Message:
Sent: 31-Jan-2018 13:24
From: John Beasley
Subject: Refuse to Accept

Hey RAPS!

So, this document [New Guidance] supersedes the "Refuse to Accept Policy for 510(k)s" issued August 4, 2015.

Go ahead and download your copy for review ... and please share your review notes/comments ... we learn best from each other and through our network, so let us know how this new guidance might impact you.

Thanks.


------------------------------
John Beasley RAC
Founder and Senior Consultant
3M
Henderson NV
United States
------------------------------

I always include it. Usually after the table of contents and before the body of the submission, and I will add the location of the information in the submission - where applicable.


------------------------------
Michael Nilo
Network Regulatory Partners
Portland OR
United States
------------------------------

Original Message:
Sent: 02-Feb-2018 12:00
From: Daniel Petersen
Subject: Refuse to Accept

Thank you for the update and notification of this new guidance.  I will read and provide feedback shortly.  I have a somewhat similar question with regards to the checklist and what others are doing.  We have always historically filled out the checklist and submitted it with the applications, however I note that it is "optional".  What do others do and why? Does anyone routinely NOT provide a filled checklist?  Thanks.

------------------------------
Daniel Petersen
RA Specialist
Draper UT
United States

Original Message:
Sent: 01-Feb-2018 04:54
From: Richard Vincins
Subject: Refuse to Accept

Definitely a good document to read, digest, and follow if you are working on 510(k)s.  In the past, I had used the FDA's own checklist during our technical review (peer review) of 510(k) submission as the last step prior to be submitted which worked really well.  We went from around receiving 70% RTA down to less than 20%.  This was also supported not only following the checklist, but also understanding the needs and expectations of FDA reviewers.  It is a must to follow !  Don't let your company waste time or have to tell your CEO that the 510(k) is delayed because you didn't look at this document !

------------------------------
Richard Vincins RAC
Vice President Regulatory Affairs

Original Message:
Sent: 31-Jan-2018 13:24
From: John Beasley
Subject: Refuse to Accept

Hey RAPS!

So, this document [New Guidance] supersedes the "Refuse to Accept Policy for 510(k)s" issued August 4, 2015.

Go ahead and download your copy for review ... and please share your review notes/comments ... we learn best from each other and through our network, so let us know how this new guidance might impact you.

Thanks.


------------------------------
John Beasley RAC
Founder and Senior Consultant
3M
Henderson NV
United States
------------------------------

"Does anyone routinely NOT provide a filled checklist?"

​Judging by the high percentage of 510(k)s that FDA refuses to accept, apparently so.  :)

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 02-Feb-2018 12:00
From: Daniel Petersen
Subject: Refuse to Accept

Thank you for the update and notification of this new guidance.  I will read and provide feedback shortly.  I have a somewhat similar question with regards to the checklist and what others are doing.  We have always historically filled out the checklist and submitted it with the applications, however I note that it is "optional".  What do others do and why? Does anyone routinely NOT provide a filled checklist?  Thanks.

------------------------------
Daniel Petersen
RA Specialist
Draper UT
United States

Original Message:
Sent: 01-Feb-2018 04:54
From: Richard Vincins
Subject: Refuse to Accept

Definitely a good document to read, digest, and follow if you are working on 510(k)s.  In the past, I had used the FDA's own checklist during our technical review (peer review) of 510(k) submission as the last step prior to be submitted which worked really well.  We went from around receiving 70% RTA down to less than 20%.  This was also supported not only following the checklist, but also understanding the needs and expectations of FDA reviewers.  It is a must to follow !  Don't let your company waste time or have to tell your CEO that the 510(k) is delayed because you didn't look at this document !

------------------------------
Richard Vincins RAC
Vice President Regulatory Affairs

Original Message:
Sent: 31-Jan-2018 13:24
From: John Beasley
Subject: Refuse to Accept

Hey RAPS!

So, this document [New Guidance] supersedes the "Refuse to Accept Policy for 510(k)s" issued August 4, 2015.

Go ahead and download your copy for review ... and please share your review notes/comments ... we learn best from each other and through our network, so let us know how this new guidance might impact you.

Thanks.


------------------------------
John Beasley RAC
Founder and Senior Consultant
3M
Henderson NV
United States
------------------------------