Regulatory Open Forum

Hi David,

I would like to see less room for individual reviewer interpretation of the checklist questions. What is acceptable to one reviewer triggers an RTA from another, and this should be unacceptable to both industry and FDA alike.

One RTA comment received recently was "There is no section on the purpose of the submission. Please provide a statement on the purpose of the 510(k) submission." I'm not sure where this requirement comes from - I certainly couldn't find such a requirement in the regulation or the guidance, and I have never been asked for this previously in over 35 years of writing 510(k)s.

Another RTA response was because a photo of the device on the front cover of the submission did not have a figure number, even though it was not referred to in the rest of the submission.

So, reworking some of the RTA questions to make them less open to interpretation is my request, although I appreciate how difficult this will be.

Roger

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Rome, Italy
+39 06 578 2665
rgray@donawa.com
------------------------------

Original Message:
Sent: 14-Jul-2017 11:20
From: David Lim
Subject: 21st Century Cures Act and FDA's Refuse to Accept Policy (RTA)

Dear All:

After the 21st Century Cures Act was signed into law (Dec 13, 2016), FDA is in the process of revising the RTA policy guidance, issued on Aug. 4, 2015. 

What sections in the RTA guidance do you think it should be revised? 

I'd like to see your views on the question.  

Thank you.

s/ David

______________________________________________

Dr. David Lim, Ph.D., RAC, ASQ-CQA 

REGULATORY DOCTOR

http://www.regulatorydoctor.US

Phone (Toll-Free): 1-(800) 321-8567

E-mail:  David@RegulatoryDoctor.US

NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.

Before you can effectively reduce inappropriate RTA questions resulting from individual reviewer (mis?)interpretation of questions that are too open to interpretation, you have to identify those questions that are the source of inappropriate RTA comments because they are too open to interpretation.

Which RTA questions did you determine were responsible for the inappropriate RTA comments in your examples?

------------------------------
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: 15-Jul-2017 06:49
From: Roger Gray
Subject: 21st Century Cures Act and FDA's Refuse to Accept Policy (RTA)

Hi David,

I would like to see less room for individual reviewer interpretation of the checklist questions. What is acceptable to one reviewer triggers an RTA from another, and this should be unacceptable to both industry and FDA alike.

One RTA comment received recently was "There is no section on the purpose of the submission. Please provide a statement on the purpose of the 510(k) submission." I'm not sure where this requirement comes from - I certainly couldn't find such a requirement in the regulation or the guidance, and I have never been asked for this previously in over 35 years of writing 510(k)s.

Another RTA response was because a photo of the device on the front cover of the submission did not have a figure number, even though it was not referred to in the rest of the submission.

So, reworking some of the RTA questions to make them less open to interpretation is my request, although I appreciate how difficult this will be.

Roger

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Rome, Italy
+39 06 578 2665
rgray@donawa.com
------------------------------

Original Message:
Sent: 14-Jul-2017 11:20
From: David Lim
Subject: 21st Century Cures Act and FDA's Refuse to Accept Policy (RTA)

Dear All:

After the 21st Century Cures Act was signed into law (Dec 13, 2016), FDA is in the process of revising the RTA policy guidance, issued on Aug. 4, 2015. 

What sections in the RTA guidance do you think it should be revised? 

I'd like to see your views on the question.  

Thank you.

s/ David

______________________________________________

Dr. David Lim, Ph.D., RAC, ASQ-CQA 

REGULATORY DOCTOR

http://www.regulatorydoctor.US

Phone (Toll-Free): 1-(800) 321-8567

E-mail:  David@RegulatoryDoctor.US

NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.

It should help if the interactive review period between the FDA checklist reviewers and the submitter is optimized. The update effort is largely directed at completeness for substantive review to take place in an efficient manner.

We could establish an industry best practices document with accumulative RAPS insight on each 510k checklist. 

Regards



------------------------------
Gurdyal Kalsi MD
Chief Medical Officer
SVP Medical/Clinical/Regulatory
JHU Rockville Campus
9605 Medical Center Drive
Rockville MD
United States
------------------------------

Original Message:
Sent: 14-Jul-2017 11:20
From: David Lim
Subject: 21st Century Cures Act and FDA's Refuse to Accept Policy (RTA)

Dear All:

After the 21st Century Cures Act was signed into law (Dec 13, 2016), FDA is in the process of revising the RTA policy guidance, issued on Aug. 4, 2015. 

What sections in the RTA guidance do you think it should be revised? 

I'd like to see your views on the question.  

Thank you.

s/ David

______________________________________________

Dr. David Lim, Ph.D., RAC, ASQ-CQA 

REGULATORY DOCTOR

http://www.regulatorydoctor.US

Phone (Toll-Free): 1-(800) 321-8567

E-mail:  David@RegulatoryDoctor.US

NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.

My main comment is that I would be inclined to discount any suggestions on changes to THE GUIDANCE based on experience with THE REVIEW PROCESS in the first two years after the guidance was issued.

The guidance serves to direct the review process, but, as we all know from long experience with the implementation of new regulations, policies, and guidances, until everyone involved (FDA and industry) has worked through the learning curve, that experience is with the learning curve, not with the new regulation, policy, or guidance.

Once you get past the learning curve, then you can evaluate the process that actually resulted from the guidance, and reasonably identify aspects of the guidance that, if changed, might improve that process.

------------------------------
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: 14-Jul-2017 11:20
From: David Lim
Subject: 21st Century Cures Act and FDA's Refuse to Accept Policy (RTA)

Dear All:

After the 21st Century Cures Act was signed into law (Dec 13, 2016), FDA is in the process of revising the RTA policy guidance, issued on Aug. 4, 2015. 

What sections in the RTA guidance do you think it should be revised? 

I'd like to see your views on the question.  

Thank you.

s/ David

______________________________________________

Dr. David Lim, Ph.D., RAC, ASQ-CQA 

REGULATORY DOCTOR

http://www.regulatorydoctor.US

Phone (Toll-Free): 1-(800) 321-8567

E-mail:  David@RegulatoryDoctor.US

NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.

BTW, does anyone have updated figures on the percent of 510(k)s that are rejected?   I looked for these figures in some of the MDUFA reports at one time, but didn't see them.

------------------------------
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: 14-Jul-2017 11:20
From: David Lim
Subject: 21st Century Cures Act and FDA's Refuse to Accept Policy (RTA)

Dear All:

After the 21st Century Cures Act was signed into law (Dec 13, 2016), FDA is in the process of revising the RTA policy guidance, issued on Aug. 4, 2015. 

What sections in the RTA guidance do you think it should be revised? 

I'd like to see your views on the question.  

Thank you.

s/ David

______________________________________________

Dr. David Lim, Ph.D., RAC, ASQ-CQA 

REGULATORY DOCTOR

http://www.regulatorydoctor.US

Phone (Toll-Free): 1-(800) 321-8567

E-mail:  David@RegulatoryDoctor.US

NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.

It depends a bit on how you cut the math, but based on the MDUFA 3 report from the Jan-Mar quarter 2017, it appears to be around 43%-44% are rejected via RTA on the first pass. It appears quite a few do get through on a 2nd pass. Interestingly, on our most recent 510(k), we got a letter saying {paraphrased] "We did not complete RTA review because we missed the deadline. Thus we are accepting your 510(k). This does not mean it is complete or acceptable" Huh?

g-

------------------------------
Ginger Glaser RAC
Vice-President, Quality and Regulatory Affairs
Maplewood MN
United States
------------------------------

Original Message:
Sent: 15-Jul-2017 12:11
From: Julie Omohundro
Subject: 21st Century Cures Act and FDA's Refuse to Accept Policy (RTA)

BTW, does anyone have updated figures on the percent of 510(k)s that are rejected?   I looked for these figures in some of the MDUFA reports at one time, but didn't see them.

------------------------------
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: 14-Jul-2017 11:20
From: David Lim
Subject: 21st Century Cures Act and FDA's Refuse to Accept Policy (RTA)

Dear All:

After the 21st Century Cures Act was signed into law (Dec 13, 2016), FDA is in the process of revising the RTA policy guidance, issued on Aug. 4, 2015. 

What sections in the RTA guidance do you think it should be revised? 

I'd like to see your views on the question.  

Thank you.

s/ David

______________________________________________

Dr. David Lim, Ph.D., RAC, ASQ-CQA 

REGULATORY DOCTOR

http://www.regulatorydoctor.US

Phone (Toll-Free): 1-(800) 321-8567

E-mail:  David@RegulatoryDoctor.US

NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.

Oh - I used page 205 of the report for the stats, if you care.

g-

------------------------------
Ginger Glaser RAC
Vice-President, Quality and Regulatory Affairs
Maplewood MN
United States
------------------------------

Original Message:
Sent: 21-Jul-2017 08:47
From: Ginger Glaser
Subject: 21st Century Cures Act and FDA's Refuse to Accept Policy (RTA)

It depends a bit on how you cut the math, but based on the MDUFA 3 report from the Jan-Mar quarter 2017, it appears to be around 43%-44% are rejected via RTA on the first pass. It appears quite a few do get through on a 2nd pass. Interestingly, on our most recent 510(k), we got a letter saying {paraphrased] "We did not complete RTA review because we missed the deadline. Thus we are accepting your 510(k). This does not mean it is complete or acceptable" Huh?

g-

------------------------------
Ginger Glaser RAC
Vice-President, Quality and Regulatory Affairs
Maplewood MN
United States
------------------------------

Original Message:
Sent: 15-Jul-2017 12:11
From: Julie Omohundro
Subject: 21st Century Cures Act and FDA's Refuse to Accept Policy (RTA)

BTW, does anyone have updated figures on the percent of 510(k)s that are rejected?   I looked for these figures in some of the MDUFA reports at one time, but didn't see them.

------------------------------
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: 14-Jul-2017 11:20
From: David Lim
Subject: 21st Century Cures Act and FDA's Refuse to Accept Policy (RTA)

Dear All:

After the 21st Century Cures Act was signed into law (Dec 13, 2016), FDA is in the process of revising the RTA policy guidance, issued on Aug. 4, 2015. 

What sections in the RTA guidance do you think it should be revised? 

I'd like to see your views on the question.  

Thank you.

s/ David

______________________________________________

Dr. David Lim, Ph.D., RAC, ASQ-CQA 

REGULATORY DOCTOR

http://www.regulatorydoctor.US

Phone (Toll-Free): 1-(800) 321-8567

E-mail:  David@RegulatoryDoctor.US

NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.

​Yes, thanks.  I've been thinking if I could find it in one report, then I could probably figure out where to look for it in others.

------------------------------
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: 21-Jul-2017 08:48
From: Ginger Glaser
Subject: 21st Century Cures Act and FDA's Refuse to Accept Policy (RTA)

Oh - I used page 205 of the report for the stats, if you care.

g-

------------------------------
Ginger Glaser RAC
Vice-President, Quality and Regulatory Affairs
Maplewood MN
United States
------------------------------

Original Message:
Sent: 21-Jul-2017 08:47
From: Ginger Glaser
Subject: 21st Century Cures Act and FDA's Refuse to Accept Policy (RTA)

It depends a bit on how you cut the math, but based on the MDUFA 3 report from the Jan-Mar quarter 2017, it appears to be around 43%-44% are rejected via RTA on the first pass. It appears quite a few do get through on a 2nd pass. Interestingly, on our most recent 510(k), we got a letter saying {paraphrased] "We did not complete RTA review because we missed the deadline. Thus we are accepting your 510(k). This does not mean it is complete or acceptable" Huh?

g-

------------------------------
Ginger Glaser RAC
Vice-President, Quality and Regulatory Affairs
Maplewood MN
United States
------------------------------

Original Message:
Sent: 15-Jul-2017 12:11
From: Julie Omohundro
Subject: 21st Century Cures Act and FDA's Refuse to Accept Policy (RTA)

BTW, does anyone have updated figures on the percent of 510(k)s that are rejected?   I looked for these figures in some of the MDUFA reports at one time, but didn't see them.

------------------------------
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: 14-Jul-2017 11:20
From: David Lim
Subject: 21st Century Cures Act and FDA's Refuse to Accept Policy (RTA)

Dear All:

After the 21st Century Cures Act was signed into law (Dec 13, 2016), FDA is in the process of revising the RTA policy guidance, issued on Aug. 4, 2015. 

What sections in the RTA guidance do you think it should be revised? 

I'd like to see your views on the question.  

Thank you.

s/ David

______________________________________________

Dr. David Lim, Ph.D., RAC, ASQ-CQA 

REGULATORY DOCTOR

http://www.regulatorydoctor.US

Phone (Toll-Free): 1-(800) 321-8567

E-mail:  David@RegulatoryDoctor.US

NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.

​I think what they may have been trying to say is that they were accepting it for review, but that they hadn't excluded the possibility that the review would still find it incomplete or otherwise not meeting some of the criteria for acceptance.

------------------------------
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: 21-Jul-2017 08:47
From: Ginger Glaser
Subject: 21st Century Cures Act and FDA's Refuse to Accept Policy (RTA)

It depends a bit on how you cut the math, but based on the MDUFA 3 report from the Jan-Mar quarter 2017, it appears to be around 43%-44% are rejected via RTA on the first pass. It appears quite a few do get through on a 2nd pass. Interestingly, on our most recent 510(k), we got a letter saying {paraphrased] "We did not complete RTA review because we missed the deadline. Thus we are accepting your 510(k). This does not mean it is complete or acceptable" Huh?

g-

------------------------------
Ginger Glaser RAC
Vice-President, Quality and Regulatory Affairs
Maplewood MN
United States
------------------------------

Original Message:
Sent: 15-Jul-2017 12:11
From: Julie Omohundro
Subject: 21st Century Cures Act and FDA's Refuse to Accept Policy (RTA)

BTW, does anyone have updated figures on the percent of 510(k)s that are rejected?   I looked for these figures in some of the MDUFA reports at one time, but didn't see them.

------------------------------
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: 14-Jul-2017 11:20
From: David Lim
Subject: 21st Century Cures Act and FDA's Refuse to Accept Policy (RTA)

Dear All:

After the 21st Century Cures Act was signed into law (Dec 13, 2016), FDA is in the process of revising the RTA policy guidance, issued on Aug. 4, 2015. 

What sections in the RTA guidance do you think it should be revised? 

I'd like to see your views on the question.  

Thank you.

s/ David

______________________________________________

Dr. David Lim, Ph.D., RAC, ASQ-CQA 

REGULATORY DOCTOR

http://www.regulatorydoctor.US

Phone (Toll-Free): 1-(800) 321-8567

E-mail:  David@RegulatoryDoctor.US

NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.