Can we submit data with Special 510(k)?

J

Jennifer27

Hi Experts,

My company is planning to submit a special 510(k) - a modification to our own device. However, the modification is material change of patient contacting part of the device. Since, I think NO DATA can be submitted as a part of a Special 510(k) I am thinking we should do a traditional 510(k). Because for patient contacting material change FDA might want to see Biocompatibility report and since DATA cannot be submitted in a Special 510(k), FDA might convert the Special 510(k) to a Traditional 510(k). Please let me know what you think -

Can we submit data with a special 510(k)? Is there any guidance document which clarifies this?
For a patient contacting material change, would FDA want to see biocompatibility test data?


I look forward to hear from you,

Best,

Jen


 

Ronen E

Problem Solver
Moderator
Can we submit data with a special 510(k)?
Why do you think you can't?

For a patient contacting material change, would FDA want to see biocompatibility test data?
They would probably want to see a test report, unless you can establish that testing is not required (depends on the specifics). AFAIK a biocompatibility test report is not the same as biocompatibility test data.

Cheers,
Ronen.
 
A

Aaria

For material changes, FDA does expect a PMN submission.

There is no specific written rule that NO data can be submitted for special 510k. The submission type (special/traditional) should not be derived from the fact whether we need to submit data or not. Why to increase a submission review cycle (60 d vs 30 d), right?

You can justify through your regulatory assessment how special 510(k) would only apply. I am assuming material change for your device classification does not trickle down an intended use change. In that case traditional would apply.

PS: I've submitted special 510k(s) which contained complete battery of biocompatibility tests and reports.

Hope this helps.

Thanks,
Aaria
 
C

Critical Care

About the 510(k) eligiblity about material change:

A change, however, in formulation in a material or a change to a type of material that hasbeen used in other legally marketed devices within the same classification regulation for the same intended use could be reviewed as a Special 510(k). This should be true for both non-contacting devices as well as implants and devices that contact body tissues or fluids. Thus, a manufacturer of a hip implant could change from one alloy to one that has been used in another legally marketed predicate through the submission of a Special 510(k).

Similarly, a contact lens manufacturer could submit a Special 510(k) for a change in their polymer to another material that has been used in a legally marketed predicate. Finally, changes in an inactive or secondary ingredient/agent should be appropriate for review as Special 510(k)s as this should not be considered a major change to the fundamental scientific Technology of the device. For example, a manufacturer of a urologic catheter
could submit a Special 510(k) to add an antimicrobial coating to the device if the coating has been used on another legally marketed predicate of the same material.

About Documentation now:
FDA want you to rely on your design control activites statement. About test results, you could provide a table (best practice) with test activities ID, Standard reference ID, Acceptance criterias & results (pass/fail) only.
Not your full validation documents


Hope this will help !
 

Michael Malis

Quite Involved in Discussions
Hi Experts,

My company is planning to submit a special 510(k) - a modification to our own device. However, the modification is material change of patient contacting part of the device. Since, I think NO DATA can be submitted as a part of a Special 510(k) I am thinking we should do a traditional 510(k). Because for patient contacting material change FDA might want to see Biocompatibility report and since DATA cannot be submitted in a Special 510(k)....
For a patient contacting material change, would FDA want to see biocompatibility test data?...

Jen,

FDA's "decision tree" is very specific about special vs. traditional submission.

What is the classification and Risk of your device? Is it contacting the skin or blood? Based on answers, it will be more or less probable of FDA interest in your 510(k) details.

However, FDA most definitely will want to see biocompatibility data. Biocompatibility (and specifically, color additives) is the latest agency focus.

The bottom line, please make sure that you have a COMPLETE set of biocompatibility data (not just partial testing) for your material change.

Good luck,
Michael
 
Last edited by a moderator:
T

tallu

My latest experience with the FDA was that they were very satisfied of detailed biocompatibility summary report of performed tests and data analysis.

Key facts of biocompatibility and performed tests was explained in summary report. Reference to original reports and data was pointed out to exist in device design dossier (DHF).

All thought they asked the original test reports for review but it did not raised any new issues of biocompatibility or delayed the 510k process.

They did not asked any data for review.

But IVD devices or devices with high risk rating/class might face different evaluation principles.
 
J

Julie O

Can we submit data with a special 510(k)? Is there any guidance document which clarifies this?


FDA's online guidance for Special 510(k)s is here:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134573.htm#content

Note that under Content and Format, it lists:

- Information on sterilization, biocompatibility, expiration date, etc., if applicable.

I'm pretty sure data fall under the category of information.

Based on the decision tree, I don't see how this gets converted to a Traditional 510(k). Biocompatibility testing is normally part of the design control process. I think this would take you straight down the tree to a Special 510(k).
 
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