Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear RAPS members,

I have an upcoming submission in July end and I will start writing the sections soon. Please share your opinion on your plan of action when writing a 510(k). How do you approach each section? time estimate for writing, approach to writing each section, best practices and any advice/caution.

Here is my approach:

1) I am going to begin with Appendix for each section to ensure other departments are aware of the deliverables that need to be submitted. 
2) Download latest guidance and forms
3)  Fill out administrative forms (indication for use, RTA checklist & cover sheet etc) and document  the leftover sections in schedule sheet that need to be addressed right before submission- estimated to complete in 2- 4 days
4) Complete sections that are N/A by providing rationale for N/A- estimated to complete in 1 day
5) Cover letter and 510k statement- estimated to complete in 2-5 days
6) Device description - estimated to complete in 1 week
7) Proposed labeling- estimated to complete in 1 day
8) Exec summary and SE discussion- estimated to complete in 2 weeks
9) Software followed by other sections- estimated to complete in 2-3 week3
10) Formatting and building the ecopy - 1 week

Thanks in advance

Hi, sounds like a good approach. What I like to do is make a table/list in the 510(k) format that we follow-up with relevant stakeholders weekly:
0. 510(k) acceptance checklist
1. Medical Device User Fee Cover Sheet (FDA Form 3601)
2. CDRH Premarket Review Submission Cover Sheet (FDA Form 3514)
3. 510(k) Cover Letter
4. Indications for Use Statement (FDA Form 3881)
5. 510(k) Summary
6. Truthful and Accuracy Statement
7. Class III Summary and Certification
8. Financial Certification and/or Disclosure Statement (FDA Form 3454)
9. Declarations of Conformity and Summary Reports
10. Device Description
11. Executive Summary
12. Substantial Equivalence Discussion
13. Proposed Labelling
14. Sterilization and Shelf Life
15. Biocompatibility
16. Software and Cybersecurity
17. Electromagnetic Compatibility and Electrical Safety
18. Performance Testing – Bench
19. Performance Testing – Animal
20. Performance Testing – Clinical
21. Usability and Human factors
22. Summary of Design Control Activities
23. Attachments/Others

Some of the parts are best when done as last items, such as exec. summary and 510(k) summary and cover letter.
Hope this helps,

------------------------------
Hannes Hyvönen
RA Manager at Icare Finland
Vantaa
Finland
------------------------------

Original Message:
Sent: 10-May-2020 23:06
From: Anonymous Member
Subject: Approach to writing 510(k)

This message was posted by a user wishing to remain anonymous

Dear RAPS members,

I have an upcoming submission in July end and I will start writing the sections soon. Please share your opinion on your plan of action when writing a 510(k). How do you approach each section? time estimate for writing, approach to writing each section, best practices and any advice/caution.

Here is my approach:

1) I am going to begin with Appendix for each section to ensure other departments are aware of the deliverables that need to be submitted.
2) Download latest guidance and forms
3)  Fill out administrative forms (indication for use, RTA checklist & cover sheet etc) and document  the leftover sections in schedule sheet that need to be addressed right before submission- estimated to complete in 2- 4 days
4) Complete sections that are N/A by providing rationale for N/A- estimated to complete in 1 day
5) Cover letter and 510k statement- estimated to complete in 2-5 days
6) Device description - estimated to complete in 1 week
7) Proposed labeling- estimated to complete in 1 day
8) Exec summary and SE discussion- estimated to complete in 2 weeks
9) Software followed by other sections- estimated to complete in 2-3 week3
10) Formatting and building the ecopy - 1 week

Thanks in advance

Hello Anon,

You might get some friendly advice, though what you are asking is some trade secrets for hire individuals working on 510(k) submissions.  A couple recommendations is there is plenty of information on the FDA's website describing content of a 510(k), there are some training materials out there, or retain a consultant to help walk you through your submission process to understand advice, best practices, and common pitfalls.  I would say estimate for compiling a 510(k) can take anywhere from straight 2 weeks of work, to a month of working on submission and other projects, to more than a month depending on schedule and more importantly the condition of your source documents.  The actual writing part may not take that long, but if your source documents, i.e. software documents, validation reports, etc., are not so good, it will take longer to compile.

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

Original Message:
Sent: 12-May-2020 04:42
From: Hannes Hyvönen
Subject: Approach to writing 510(k)

Hi, sounds like a good approach. What I like to do is make a table/list in the 510(k) format that we follow-up with relevant stakeholders weekly:
0. 510(k) acceptance checklist
1. Medical Device User Fee Cover Sheet (FDA Form 3601)
2. CDRH Premarket Review Submission Cover Sheet (FDA Form 3514)
3. 510(k) Cover Letter
4. Indications for Use Statement (FDA Form 3881)
5. 510(k) Summary
6. Truthful and Accuracy Statement
7. Class III Summary and Certification
8. Financial Certification and/or Disclosure Statement (FDA Form 3454)
9. Declarations of Conformity and Summary Reports
10. Device Description
11. Executive Summary
12. Substantial Equivalence Discussion
13. Proposed Labelling
14. Sterilization and Shelf Life
15. Biocompatibility
16. Software and Cybersecurity
17. Electromagnetic Compatibility and Electrical Safety
18. Performance Testing – Bench
19. Performance Testing – Animal
20. Performance Testing – Clinical
21. Usability and Human factors
22. Summary of Design Control Activities
23. Attachments/Others

Some of the parts are best when done as last items, such as exec. summary and 510(k) summary and cover letter.
Hope this helps,

------------------------------
Hannes Hyvönen
RA Manager at Icare Finland
Vantaa
Finland

Original Message:
Sent: 10-May-2020 23:06
From: Anonymous Member
Subject: Approach to writing 510(k)

This message was posted by a user wishing to remain anonymous

Dear RAPS members,

I have an upcoming submission in July end and I will start writing the sections soon. Please share your opinion on your plan of action when writing a 510(k). How do you approach each section? time estimate for writing, approach to writing each section, best practices and any advice/caution.

Here is my approach:

1) I am going to begin with Appendix for each section to ensure other departments are aware of the deliverables that need to be submitted.
2) Download latest guidance and forms
3)  Fill out administrative forms (indication for use, RTA checklist & cover sheet etc) and document  the leftover sections in schedule sheet that need to be addressed right before submission- estimated to complete in 2- 4 days
4) Complete sections that are N/A by providing rationale for N/A- estimated to complete in 1 day
5) Cover letter and 510k statement- estimated to complete in 2-5 days
6) Device description - estimated to complete in 1 week
7) Proposed labeling- estimated to complete in 1 day
8) Exec summary and SE discussion- estimated to complete in 2 weeks
9) Software followed by other sections- estimated to complete in 2-3 week3
10) Formatting and building the ecopy - 1 week

Thanks in advance

I agree with  Richard on this, especially  with regard to quality  of source documents.  Some companies think the RA professional just compiles  and sends it in. My experience  working in large and small companies, both as employee and as a consultant is that RA should really be reviewing the quality of presentation, and consistency and adequacy of the messaging (technical story)  throughout the supporting documents.  RA weaves it all together and better understand what they are submitting, because RA is acting as last pass internal review before it goes to FDA.  Not all engineers  write well or understand how to present the story to a regulatory agency, NB, or auditor. 

Don't  get surprised by what is in your submission.  You should  know the strength or weaknesses in what you submit and be prepared  to respond  to AI letters. Have a plan going in, by reviewing as if you were FDA. 

Should you want an external review of your completed submission  before you send it in, working with a consultant  is not a bad option.  A second pair of eyes is helpful, because I can tell you that after you have worked on a submission draft over and over, sometimes you don't  even see the issues that are still there in the final submission  (This is why book authors have editors).

Good luck!

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

Original Message:
Sent: 12-May-2020 04:56
From: Richard Vincins
Subject: Approach to writing 510(k)

Hello Anon,

You might get some friendly advice, though what you are asking is some trade secrets for hire individuals working on 510(k) submissions.  A couple recommendations is there is plenty of information on the FDA's website describing content of a 510(k), there are some training materials out there, or retain a consultant to help walk you through your submission process to understand advice, best practices, and common pitfalls.  I would say estimate for compiling a 510(k) can take anywhere from straight 2 weeks of work, to a month of working on submission and other projects, to more than a month depending on schedule and more importantly the condition of your source documents.  The actual writing part may not take that long, but if your source documents, i.e. software documents, validation reports, etc., are not so good, it will take longer to compile.

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

Original Message:
Sent: 12-May-2020 04:42
From: Hannes Hyvönen
Subject: Approach to writing 510(k)

Hi, sounds like a good approach. What I like to do is make a table/list in the 510(k) format that we follow-up with relevant stakeholders weekly:
0. 510(k) acceptance checklist
1. Medical Device User Fee Cover Sheet (FDA Form 3601)
2. CDRH Premarket Review Submission Cover Sheet (FDA Form 3514)
3. 510(k) Cover Letter
4. Indications for Use Statement (FDA Form 3881)
5. 510(k) Summary
6. Truthful and Accuracy Statement
7. Class III Summary and Certification
8. Financial Certification and/or Disclosure Statement (FDA Form 3454)
9. Declarations of Conformity and Summary Reports
10. Device Description
11. Executive Summary
12. Substantial Equivalence Discussion
13. Proposed Labelling
14. Sterilization and Shelf Life
15. Biocompatibility
16. Software and Cybersecurity
17. Electromagnetic Compatibility and Electrical Safety
18. Performance Testing – Bench
19. Performance Testing – Animal
20. Performance Testing – Clinical
21. Usability and Human factors
22. Summary of Design Control Activities
23. Attachments/Others

Some of the parts are best when done as last items, such as exec. summary and 510(k) summary and cover letter.
Hope this helps,

------------------------------
Hannes Hyvönen
RA Manager at Icare Finland
Vantaa
Finland

Original Message:
Sent: 10-May-2020 23:06
From: Anonymous Member
Subject: Approach to writing 510(k)

This message was posted by a user wishing to remain anonymous

Dear RAPS members,

I have an upcoming submission in July end and I will start writing the sections soon. Please share your opinion on your plan of action when writing a 510(k). How do you approach each section? time estimate for writing, approach to writing each section, best practices and any advice/caution.

Here is my approach:

1) I am going to begin with Appendix for each section to ensure other departments are aware of the deliverables that need to be submitted.
2) Download latest guidance and forms
3)  Fill out administrative forms (indication for use, RTA checklist & cover sheet etc) and document  the leftover sections in schedule sheet that need to be addressed right before submission- estimated to complete in 2- 4 days
4) Complete sections that are N/A by providing rationale for N/A- estimated to complete in 1 day
5) Cover letter and 510k statement- estimated to complete in 2-5 days
6) Device description - estimated to complete in 1 week
7) Proposed labeling- estimated to complete in 1 day
8) Exec summary and SE discussion- estimated to complete in 2 weeks
9) Software followed by other sections- estimated to complete in 2-3 week3
10) Formatting and building the ecopy - 1 week

Thanks in advance

Hi Anon,

Only you can estimate how fast your writing process and the internal review process are likely to take, so I am not sure others estimates will help - those with more experience may be faster, some people just write fast etc. What I will say is that experience tells me you need to "work in parallel to the team" as best you can. At most companies, saying "I need a month to complete the 510(k) after the last R&D deliverable is in my hands" won't come across very well. Generally, the most tolerance you will get is about 2 weeks. I've found (for me and my staff over the years) that the 2 weeks can usually be hit if you have written sections as the test reports, drawings etc come in or even from drafts you review come in during the project (though using drafts does require double checking later). Then the "final" report that comes in just has to get summarized, final conclusions checked, entire document reviewed by whomever your process indicates and all the assembly and electronic stuff get done - easy to meet or beat 2 weeks at that point.

Obviously, the above breaks down if you get a huge amount of reports completed at the last minute :-)

Good luck!

g-

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

Original Message:
Sent: 10-May-2020 23:06
From: Anonymous Member
Subject: Approach to writing 510(k)

This message was posted by a user wishing to remain anonymous

Dear RAPS members,

I have an upcoming submission in July end and I will start writing the sections soon. Please share your opinion on your plan of action when writing a 510(k). How do you approach each section? time estimate for writing, approach to writing each section, best practices and any advice/caution.

Here is my approach:

1) I am going to begin with Appendix for each section to ensure other departments are aware of the deliverables that need to be submitted.
2) Download latest guidance and forms
3)  Fill out administrative forms (indication for use, RTA checklist & cover sheet etc) and document  the leftover sections in schedule sheet that need to be addressed right before submission- estimated to complete in 2- 4 days
4) Complete sections that are N/A by providing rationale for N/A- estimated to complete in 1 day
5) Cover letter and 510k statement- estimated to complete in 2-5 days
6) Device description - estimated to complete in 1 week
7) Proposed labeling- estimated to complete in 1 day
8) Exec summary and SE discussion- estimated to complete in 2 weeks
9) Software followed by other sections- estimated to complete in 2-3 week3
10) Formatting and building the ecopy - 1 week

Thanks in advance

I agree with the approach you've outlined and advice given by others. I usually leave the Executive Summary and cover letter until the other sections are drafted. ​This can help with the cohesiveness of the submission and confidence of your "voice" for those parts. I also recommend having subject matter experts review the submission prior to formatting/ final submission. Sometimes in summarizing, the meaning can be changed, and it's important that the experts confirm it's all accurate.

------------------------------
Teresa Skarr RAC
Distinguished RA Advisor
Santa Rosa, CA
United States
------------------------------

Original Message:
Sent: 10-May-2020 23:06
From: Anonymous Member
Subject: Approach to writing 510(k)

This message was posted by a user wishing to remain anonymous

Dear RAPS members,

I have an upcoming submission in July end and I will start writing the sections soon. Please share your opinion on your plan of action when writing a 510(k). How do you approach each section? time estimate for writing, approach to writing each section, best practices and any advice/caution.

Here is my approach:

1) I am going to begin with Appendix for each section to ensure other departments are aware of the deliverables that need to be submitted.
2) Download latest guidance and forms
3)  Fill out administrative forms (indication for use, RTA checklist & cover sheet etc) and document  the leftover sections in schedule sheet that need to be addressed right before submission- estimated to complete in 2- 4 days
4) Complete sections that are N/A by providing rationale for N/A- estimated to complete in 1 day
5) Cover letter and 510k statement- estimated to complete in 2-5 days
6) Device description - estimated to complete in 1 week
7) Proposed labeling- estimated to complete in 1 day
8) Exec summary and SE discussion- estimated to complete in 2 weeks
9) Software followed by other sections- estimated to complete in 2-3 week3
10) Formatting and building the ecopy - 1 week

Thanks in advance