Regulatory Open Forum

Hello everyone,

We submitted a Traditional 510(k) for a new device to a third-party reviewer. We included a Declaration of Conformity to an FDA recognized consensus standard within the submission. We did not include a Complete Test Report (full protocols and reports) since the standard is an FDA recognized design standard that specifies both test methods and acceptance criteria. This aligns with the FDA guidance "Appropriate Use of Voluntary Consensus Standards in Premarket Submission for Medical Devices - Guidance for Industry and Food and Drug Administration Staff" dated September 14, 2018. The third-party review will not accept this rationale and is requiring the Complete Test Report to be included in the 510(k). The third-party reviewer believes this approach is inadequate because the FDA would expect that the complete test report is reviewed prior to a SE recommendation, but this contradicts the guidance.

We are moving forward with the complete test reports to obtain clearance, but have others run into this issue? Will FDA accept a DoC for an FDA recognized consensus standard that specifies both test methods and acceptance criteria without a complete test report?

Any suggestions/advise is appreciated. Thank you!

---------------------------------
Akanksha Asbe
Regulatory Affairs Specialist II

Clinton MA
United States
---------------------------------

We submitted a Traditional and went through the same process, except we did not use a third party review.  One of the deficiencies we received from the FDA was a request for us to provide all the test reports.

------------------------------
Colleen Powell
Director of Regulatory Affairs
Gloucestershire
United Kingdom
------------------------------

Original Message:
Sent: 21-Sep-2020 14:03
From: Akanksha Asbe
Subject: FDA Traditional 510(k) TPR

Hello everyone,

We submitted a Traditional 510(k) for a new device to a third-party reviewer. We included a Declaration of Conformity to an FDA recognized consensus standard within the submission. We did not include a Complete Test Report (full protocols and reports) since the standard is an FDA recognized design standard that specifies both test methods and acceptance criteria. This aligns with the FDA guidance "Appropriate Use of Voluntary Consensus Standards in Premarket Submission for Medical Devices - Guidance for Industry and Food and Drug Administration Staff" dated September 14, 2018. The third-party review will not accept this rationale and is requiring the Complete Test Report to be included in the 510(k). The third-party reviewer believes this approach is inadequate because the FDA would expect that the complete test report is reviewed prior to a SE recommendation, but this contradicts the guidance.

We are moving forward with the complete test reports to obtain clearance, but have others run into this issue? Will FDA accept a DoC for an FDA recognized consensus standard that specifies both test methods and acceptance criteria without a complete test report?

Any suggestions/advise is appreciated. Thank you!

---------------------------------
Akanksha Asbe
Regulatory Affairs Specialist II

Clinton MA
United States
---------------------------------

Hello Akanksha,

This is a situation where FDA's practices are not matured enough with the guidance document or consistent across the branches.  In addition, the use of consensus standards and the Declaration of Conformity highly depends on the type of device, the standard being recognised for use, and yes - still dependent on the reviewer (sub-branch).  As an example, IEC 60601-1 testing is often accepted with a DofC, the summary test report from a third party testing lab, and information who is the third party testing lab without the full 180 page testing report.  If you are claiming compliance to a recognised consensus standard where the testing is done internally - often the full testing protocol and report are expected to ensure as a company this is being done and acceptance criteria is being met.  In my experience, the only DofC submitted where I was able to submit a summary report was electrical safety testing, electrical disturbance testing, sterilisation validation, and some re-use validation.  In theory, the idea is the company makes a "declaration" against a known standard which is recognised by the FDA.  This declaration indicates what was tested, if all sections of the standard were applied, and who did the testing.  Unfortunately, the faith or confidence in this process is not fully matured including companies make a "declaration" to a standard and when FDA has requested the full testing report, nothing is provided.  Thus the confidence wavers.  Keep in mind this declaration of conformity and use of consensus standards, including the guidance documents, has wording in there about the review process can always require and review the full testing report.  The other time I have seen consensus standards and Declaration of Conformity used with only a summary report of testing is in Special 510(k)s and Abbreviated 510(k)s but these numbers are small compared to Traditional 510(k) submissions.  At some point, just like many processes, this will mature to the point where a declaration of conformity can be made with a summary of testing and would be accepted.

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

Original Message:
Sent: 22-Sep-2020 03:16
From: Colleen Powell
Subject: FDA Traditional 510(k) TPR

We submitted a Traditional and went through the same process, except we did not use a third party review.  One of the deficiencies we received from the FDA was a request for us to provide all the test reports.

------------------------------
Colleen Powell
Director of Regulatory Affairs
Gloucestershire
United Kingdom

Original Message:
Sent: 21-Sep-2020 14:03
From: Akanksha Asbe
Subject: FDA Traditional 510(k) TPR

Hello everyone,

We submitted a Traditional 510(k) for a new device to a third-party reviewer. We included a Declaration of Conformity to an FDA recognized consensus standard within the submission. We did not include a Complete Test Report (full protocols and reports) since the standard is an FDA recognized design standard that specifies both test methods and acceptance criteria. This aligns with the FDA guidance "Appropriate Use of Voluntary Consensus Standards in Premarket Submission for Medical Devices - Guidance for Industry and Food and Drug Administration Staff" dated September 14, 2018. The third-party review will not accept this rationale and is requiring the Complete Test Report to be included in the 510(k). The third-party reviewer believes this approach is inadequate because the FDA would expect that the complete test report is reviewed prior to a SE recommendation, but this contradicts the guidance.

We are moving forward with the complete test reports to obtain clearance, but have others run into this issue? Will FDA accept a DoC for an FDA recognized consensus standard that specifies both test methods and acceptance criteria without a complete test report?

Any suggestions/advise is appreciated. Thank you!

---------------------------------
Akanksha Asbe
Regulatory Affairs Specialist II

Clinton MA
United States
---------------------------------

Some FDA reviewers do this all the time. They are not supposed to, and usually you can "win" and not be asked for complete reports if you appeal up to management or to 510(k) staff, but the reviewers know that most people just give it to them, as it is "easier" than appealing and companies don't want delays. Often then companies that submit a lot of 510(k)s start putting it in up front, and "voila" 510(k)s look more like mini-PMAs day by day.

G-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN
------------------------------

Original Message:
Sent: 22-Sep-2020 03:16
From: Colleen Powell
Subject: FDA Traditional 510(k) TPR

We submitted a Traditional and went through the same process, except we did not use a third party review.  One of the deficiencies we received from the FDA was a request for us to provide all the test reports.

------------------------------
Colleen Powell
Director of Regulatory Affairs
Gloucestershire
United Kingdom

Original Message:
Sent: 21-Sep-2020 14:03
From: Akanksha Asbe
Subject: FDA Traditional 510(k) TPR

Hello everyone,

We submitted a Traditional 510(k) for a new device to a third-party reviewer. We included a Declaration of Conformity to an FDA recognized consensus standard within the submission. We did not include a Complete Test Report (full protocols and reports) since the standard is an FDA recognized design standard that specifies both test methods and acceptance criteria. This aligns with the FDA guidance "Appropriate Use of Voluntary Consensus Standards in Premarket Submission for Medical Devices - Guidance for Industry and Food and Drug Administration Staff" dated September 14, 2018. The third-party review will not accept this rationale and is requiring the Complete Test Report to be included in the 510(k). The third-party reviewer believes this approach is inadequate because the FDA would expect that the complete test report is reviewed prior to a SE recommendation, but this contradicts the guidance.

We are moving forward with the complete test reports to obtain clearance, but have others run into this issue? Will FDA accept a DoC for an FDA recognized consensus standard that specifies both test methods and acceptance criteria without a complete test report?

Any suggestions/advise is appreciated. Thank you!

---------------------------------
Akanksha Asbe
Regulatory Affairs Specialist II

Clinton MA
United States
---------------------------------

Ginger

That is true.   The amount of information one now has to spoon feed in a 510k has expanded dramatically in the past 10 years. They really are becoming  mini-PMAs.  Not only do you get asked to put in complete  protocols and reports, then you often have to explain the report - such as EMC guidance which makes you provide a summary of  the EMC testing.   Of course, that EMC guidance  has been in place for 6-7 years, so at least I have a template I created to use to populate Section 17.....

So I don't  do many DoCs.  Just put the report in and briefly summarize the testing and results.  Way easier.....  








------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 23-Sep-2020 09:18
From: Ginger Glaser
Subject: FDA Traditional 510(k) TPR

Some FDA reviewers do this all the time. They are not supposed to, and usually you can "win" and not be asked for complete reports if you appeal up to management or to 510(k) staff, but the reviewers know that most people just give it to them, as it is "easier" than appealing and companies don't want delays. Often then companies that submit a lot of 510(k)s start putting it in up front, and "voila" 510(k)s look more like mini-PMAs day by day.

G-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN

Original Message:
Sent: 22-Sep-2020 03:16
From: Colleen Powell
Subject: FDA Traditional 510(k) TPR

We submitted a Traditional and went through the same process, except we did not use a third party review.  One of the deficiencies we received from the FDA was a request for us to provide all the test reports.

------------------------------
Colleen Powell
Director of Regulatory Affairs
Gloucestershire
United Kingdom

Original Message:
Sent: 21-Sep-2020 14:03
From: Akanksha Asbe
Subject: FDA Traditional 510(k) TPR

Hello everyone,

We submitted a Traditional 510(k) for a new device to a third-party reviewer. We included a Declaration of Conformity to an FDA recognized consensus standard within the submission. We did not include a Complete Test Report (full protocols and reports) since the standard is an FDA recognized design standard that specifies both test methods and acceptance criteria. This aligns with the FDA guidance "Appropriate Use of Voluntary Consensus Standards in Premarket Submission for Medical Devices - Guidance for Industry and Food and Drug Administration Staff" dated September 14, 2018. The third-party review will not accept this rationale and is requiring the Complete Test Report to be included in the 510(k). The third-party reviewer believes this approach is inadequate because the FDA would expect that the complete test report is reviewed prior to a SE recommendation, but this contradicts the guidance.

We are moving forward with the complete test reports to obtain clearance, but have others run into this issue? Will FDA accept a DoC for an FDA recognized consensus standard that specifies both test methods and acceptance criteria without a complete test report?

Any suggestions/advise is appreciated. Thank you!

---------------------------------
Akanksha Asbe
Regulatory Affairs Specialist II

Clinton MA
United States
---------------------------------

This message was posted by a user wishing to remain anonymous

When the new guidances were issued about standards and declarations of conformity, I have interpreted them as adding more uncertainty. So I advice my teams to just submit the full test reports. It's all electronic, so not too hard. I'm surprised others have had good luck with electromagnetic disturbances, as I've had more questions on that then anything else.
Original Message:
Sent: 21-Sep-2020 14:03
From: Akanksha Asbe
Subject: FDA Traditional 510(k) TPR

Hello everyone,

We submitted a Traditional 510(k) for a new device to a third-party reviewer. We included a Declaration of Conformity to an FDA recognized consensus standard within the submission. We did not include a Complete Test Report (full protocols and reports) since the standard is an FDA recognized design standard that specifies both test methods and acceptance criteria. This aligns with the FDA guidance "Appropriate Use of Voluntary Consensus Standards in Premarket Submission for Medical Devices - Guidance for Industry and Food and Drug Administration Staff" dated September 14, 2018. The third-party review will not accept this rationale and is requiring the Complete Test Report to be included in the 510(k). The third-party reviewer believes this approach is inadequate because the FDA would expect that the complete test report is reviewed prior to a SE recommendation, but this contradicts the guidance.

We are moving forward with the complete test reports to obtain clearance, but have others run into this issue? Will FDA accept a DoC for an FDA recognized consensus standard that specifies both test methods and acceptance criteria without a complete test report?

Any suggestions/advise is appreciated. Thank you!

---------------------------------
Akanksha Asbe
Regulatory Affairs Specialist II

Clinton MA
United States
---------------------------------

I don't include DoCs in submissions, I only refer to standards for general use and include complete test reports. It's too much of a hassle and reviewer-dependent.

------------------------------
Jeffrey Freedman
Regulatory Affairs Specialist II
Lowell MA
United States
------------------------------

Original Message:
Sent: 21-Sep-2020 14:03
From: Akanksha Asbe
Subject: FDA Traditional 510(k) TPR

Hello everyone,

We submitted a Traditional 510(k) for a new device to a third-party reviewer. We included a Declaration of Conformity to an FDA recognized consensus standard within the submission. We did not include a Complete Test Report (full protocols and reports) since the standard is an FDA recognized design standard that specifies both test methods and acceptance criteria. This aligns with the FDA guidance "Appropriate Use of Voluntary Consensus Standards in Premarket Submission for Medical Devices - Guidance for Industry and Food and Drug Administration Staff" dated September 14, 2018. The third-party review will not accept this rationale and is requiring the Complete Test Report to be included in the 510(k). The third-party reviewer believes this approach is inadequate because the FDA would expect that the complete test report is reviewed prior to a SE recommendation, but this contradicts the guidance.

We are moving forward with the complete test reports to obtain clearance, but have others run into this issue? Will FDA accept a DoC for an FDA recognized consensus standard that specifies both test methods and acceptance criteria without a complete test report?

Any suggestions/advise is appreciated. Thank you!

---------------------------------
Akanksha Asbe
Regulatory Affairs Specialist II

Clinton MA
United States
---------------------------------