FDA Class III Medical Device Modification - 510k Application

T

Tiwana

#1
Hello!
I am studying a subject title "Regulatory Requirements". I have a simple question which has confused me alot. I will be thankful if anyone could clarify me on this.

A pacemaker's lead (/electrode cable) "insulation material" has changed from silicone to the novel polyurethane . In this case we have to file for 510K. I read this article on FDA website attached as PDF with this post.


The question is that whether we will have to file a new PMA 510k application or a special 510K submission would work.

I will be thankful if you could refer me to some flowchart or document which explains this.
 

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#2
Hello!
I am studying a subject title "Regulatory Requirements". I have a simple question which has confused me alot. I will be thankful if anyone could clarify me on this.

A pacemaker's lead (/electrode cable) "insulation material" has changed from silicone to the novel polyurethane . In this case we have to file for 510K. I read this article on FDA website attached as PDF with this post.


The question is that whether we will have to file a new PMA 510k application or a special 510K submission would work.

I will be thankful if you could refer me to some flowchart or document which explains this.
You used 510k and PMA in the same statement. A permanent pacemaker lead is a Class III device that requires a PMA and a change to a class III PMA device would require a PMA Supplement.
 
T

Tiwana

#3
But in this case we have changed the material of the lead. So can we submit a PMA supplement? I think we will have to file a new PMA application. Please correct me if I am wrong
 
M

MIREGMGR

#4
Same intended use, but new technology. Also, evidence of safety and effectiveness seems likely at first impression to require additional clinical data, and perhaps other new testing of a substantive nature. Thus it seems likely that something more than a basic supplement would be required.
 
S

sanjay_lingot

#5
Dear Friend,

I think you are confused with PMA ,special 510(k) & traditional 510(k).

If yours device is classfied as class-III device then you need PMA.
If yours device is class-II device & you are submission is for fisrst time then you need traditional 510(k).

As you said that the material is changed ,is this material is biocompatable & already refered/used by other company & subsquently passed this device (having changed material) as clas--II device then you need speacial 510(k).

If this is not passed by FDA as any 510(k) then I am sure you need PMA.

with kind regards

Sanjay
 
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