Regulatory Open Forum

Hello all, I'm wondering if anyone has insight on using PMA as a US market barrier for competitors?

The situation is that a class II (non-invasive therapeutic) device is seeking new indication with existing core technology (510k cleared). There is no predicate with similar indication, so it is supposed that the device will have to cleared as a class III device (IDE/PMA), or de novo pathway.
Since there is no market exclusivity for devices with first-in-class IFU, delaying competition's market entry is a key factor in considering whether to pursue PMA or de novo.
By looking at the regulations, it would appear that if competitors (of the same product code) wants to claim the same IFU, they would also have to apply through IDE/PMA process.

Some of my questions are:
1) In practice, after the device is approved through PMA, is it possible that a competitor can later gain market clearance for the new indication through 510(k)? By claiming SE to a device cleared through PMA? (and thereby avoiding all clinical work?)
2) Can a competitor (of the same product code, but varying core technology) file reclassification request to down classify the device with new IFU?
3) How much easier would it be for a competitor to gain PMA approval for the new IFU? Would the clinical requirements to show safety/efficacy be less because a similar product has gained PMA approval?

I'd really appreciate any insights to my questions!

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Ruth Pui
Product Manager / Regulatory Professional in Training
Boston MA
United States
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Stephen Goldner JD RAC
President
Regulatory Affairs Associates
Farmington Hills MI
United States
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Hi Ruth,
1.The PMA is an excellent short term barrier to market entry. FDA practice seems to be that The Agency wants to see 3 or 4 PMAs for essentially the same device so that FDA can learn the 'metes and bounds' of the science, before FDA will begin to re categorize the device down to only needing a 510k with special controls of some sort. Therefore the immediate competitors have to run across a level playing field, but eventually competitors will have an easier time of jumping the regulatory hurdles. 
2. A competitor can certainly file a reclassification request with a different IFU, but we haven't seen that work very well- because FDA considers the different IFU [usually] to be for a novel use and therefore a PMA is needed for that different IFU.
3. We have not seen FDA to any more 'lenient' on the competitor with a different IFU- and our sponsors are very vigilant to make certain their data is not used by FDA to 'clear' someone else's device. At the end of the day- it about the data for the device being put in front of FDA reviewers that must 'carry the day'; not someone else's device.


Original Message:
Sent: 08-22-2011 23:45
From: Ruth Pui
Subject: PMA as a market barrier for competitors?


Hello all, I'm wondering if anyone has insight on using PMA as a US market barrier for competitors?

The situation is that a class II (non-invasive therapeutic) device is seeking new indication with existing core technology (510k cleared). There is no predicate with similar indication, so it is supposed that the device will have to cleared as a class III device (IDE/PMA), or de novo pathway.
Since there is no market exclusivity for devices with first-in-class IFU, delaying competition's market entry is a key factor in considering whether to pursue PMA or de novo.
By looking at the regulations, it would appear that if competitors (of the same product code) wants to claim the same IFU, they would also have to apply through IDE/PMA process.

Some of my questions are:
1) In practice, after the device is approved through PMA, is it possible that a competitor can later gain market clearance for the new indication through 510(k)? By claiming SE to a device cleared through PMA? (and thereby avoiding all clinical work?)
2) Can a competitor (of the same product code, but varying core technology) file reclassification request to down classify the device with new IFU?
3) How much easier would it be for a competitor to gain PMA approval for the new IFU? Would the clinical requirements to show safety/efficacy be less because a similar product has gained PMA approval?

I'd really appreciate any insights to my questions!

-------------------------------------------
Ruth Pui
Product Manager / Regulatory Professional in Training
Boston MA
United States
-------------------------------------------