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A traditional 510K or Special 510K - Manufacturing facility and other changes

B

BigManP

#11
#11
ehoqa said:
I'd previously communicated with an FDA rep about a docket related to our device but on a different subject. I'd mentioned that we plan to change labeling regarding MR compatibility, and she said that we would have to submit a 510(k) because the MR compatability data would have to be reviewed for the claim. That was all I got, so I was wondering if a Special 510(k) would be adequate. I'm still not sure of the answer myself, but we'll be working with a 510(k) consultant to help us with the process.
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In the past we have submitted Special 510(k)s for minor design and/or material changes and as part of that added the MR Safe label and did not have any issues with it. Furthermore, I would always try a Special before a Traditional if I thought that we had a reasonable justification. They cost the same and the turn around on a Special is 30 days rather than 90. Worst case, they tell you that you that your submission is being changed to a Traditional, but you get credit for the 30 days already served. Good luck and watch out for those shady consultants! There are great ones out there, but not always easy to find.
 
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Ronen E

Ronen E

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#12
#12
BigManP said:
In the past we have submitted Special 510(k)s for minor design and/or material changes and as part of that added the MR Safe label and did not have any issues with it. Furthermore, I would always try a Special before a Traditional if I thought that we had a reasonable justification. They cost the same and the turn around on a Special is 30 days rather than 90. Worst case, they tell you that you that your submission is being changed to a Traditional, but you get credit for the 30 days already served. Good luck and watch out for those shady consultants! There are great ones out there, but not always easy to find.
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How do you tell a shady consultant from a great one, upfront?
 
B

BigManP

#13
#13
If you can figure that out, you'll be ahead of the game for sure! Unfortunately, it is pretty difficult to tell if a regulatory/quality consultant is worth anything until after they have accomplished something. We worked with a consultant for 6 months and when he left all we had to show for it was a general framework of a system for a company 100 times our size and a filing cabinet full of labeled folders with no paperwork. Good luck!
 
T

tallu

#14
#14
Could some one share good table of contents for Special 510k: device modification.

What sections are needed?
- cover letter
- Special 510k summary
- device description of modified device
- SE
- ...
 
B

BigManP

#15
#15
The FDA provides guidance at http://www.fda.gov/MedicalDevices/D...remarketNotification510k/ucm142651.htm#link_5. I have successfully submitted several Special 510(k)s using the following format.

1.0 Medical Device User Fee Cover Sheet (Form FDA 3601)
2.0 CDRH Premarket Review Submission Cover Sheet
? Standards Data Report for 510(k)s
3.0 Special 510(k) Cover Letter
? Basis for Special 510(k) Submission
? Administrative Information
4.0 Truthful and Accurate Statement
5.0 Device Information
? Submitter Info
? Manufacturer Info
? Device Name/Class/Classification/Panel
? Predicate Device
? Labeling and Intended Use
6.0 Device Description and Comparison
? Currently Cleared Device Overview and Description
? Proposed Device Overview and Description
? Device Comparison
7.0 Substantial Equivalence Discussion
8.0 Summary of Design Control Activities
? Risk Assessment Method
? Declaration of Conformity
? Design Verification Results
9.0 Sterilization and Shelf Life
10.0 Biocompatibility
11.0 Class III Summary and Certification ? Not Applicable
12.0 Appendices
? Appendix A: 510(k) Summary
? Appendix B: Proposed Labeling
? Appendix C: Indications for Use Statement
? Appendix D: Proposed Engineering Blueprints
? Appendix E: Declaration of Conformity with Design Controls

Be sure to include a Design Control Activities Summary (DCAS) table in section 8. and don't include any of the actual test data. It is kind of messed up, but I used to include both and with my last they made me send a letter telling them to not review the data. However, two weeks later when they had questions I was asked to provide the data for further explanation. Typical FDA for you. I would also recommend adding the checklist that is described in the FDA link. I have run into issues where the FDA said I was missing content, but they just couldn't find it. The checklist will direct them to the satisfaction of each requirement.

Good luck!

Paul
 
T

tallu

#16
#16
Thanks Paul!! :bigwave:

Its interesting that FDA doesn't want to see test data or evidence on device performance. They are mostly interested on dates and signs...

I had same kind of table content under work. I have included Biocompatibility and EMC sum-ups under Summary of Design Control Activities. What you think about that? Do I need to enclose biocompatibility certification/report as an exhibit, what about EMC test report.

With our previous cleared device we had some argue with the FDA on those issues.

Do you use basic form for the DCAS-table,
as example...

Modification/Feature Performed test Pass/Fail

Bluetooth Bluetooth pairing Pass
Data Logger Acquisition data recorded Pass
 
B

BigManP

#17
#17
Yes, the FDA can be very confusing. I think that they often times make things much more difficult than they have to. What type of device modification are you proposing with your Special 510(k)? I would think that biocompatibility and EMC testing should probably have summaries providing a little more detail than the DCAS table would allow, but you can certainly be the judge of that. For example, if the material and processes were identical for the existing and the proposed devices, I would address it in the DCAS table but I would also provide a separate summary that highlights the points from the original submission. In the DCAS table, the reviewer that I have had did want to see the actual test results, but didn't want to see the entire protocol. So, depending on your device pass/fail might be acceptable, but I typically will be provided physical test data (strengths, forces, etc.). For my tables, I use device modification/potential risk/verification method/acceptance criteria/results and or comments. This was the template that was provided to me from the FDA and in their example they listed physical test data as well.

Good luck!

Paul
 
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