If my company develops a class III medical device in the US, goes full FDA PMA regulatory route with preclinical trial followed by phase 1-3 multi-center clinical trials, can a competitor then use our success to submit a 510k on similar device and get to market within a year?
A PMA costs 25+ million dollars and can take 10 years for approval where as a 510K can be obtained in about 6 months for
No, a succssful PMA does not cause device reclassification. Your competitor faces the same requirements as you, presuming the Class III device has not been reduced to a Class II device in the interim. Your competitor must follow the PMA path if the device remains a Class III device. The advantage your competitor may have is potential access to your device (once approved) as a predicate device... allowing for a new point of comparison in clinical studies. However, it also could prove a disadvantage to the competitor if their device does not demonstrate non-inferiority to your device in clinical studies. To remove this as a possibility, they could instead select the previous gold standard as their predicate device, just as the "first to market" company used in their studies. An example of a device that was reclassified is digital mammography. Its original approval as a Class III device was in 2000. It was later reclassified (2010) to a Class II device, after several manufacturers were required to follow the Class III guidance. Hope this helps.
No, a succssful PMA does not cause device reclassification. Your competitor faces the same requirements as you, presuming the Class III device has not been reduced to a Class II device in the interim. Your competitor must follow the PMA path if the device remains a Class III device. The advantage your competitor may have is potential access to your device (once approved) as a predicate device... allowing for a new point of comparison in clinical studies. However, it also could prove a disadvantage to the competitor if their device does not demonstrate non-inferiority to your device in clinical studies. To remove this as a possibility, they could instead select the previous gold standard as their predicate device, just as the "first to market" company used in their studies. An example of a device that was reclassified is digital mammography. Its original approval as a Class III device was in 2000. It was later reclassified (2010) to a Class II device, after several manufacturers were required to follow the Class III guidance. Hope this helps.
Is there a facet of your device that would allow it to be patented as well as have FDA approval?
A micro-entity non-provisional patent will cost $400 with the PCT costing about $1900. The only liability is that to get other international patents based on the PCT, those patents will have to be filed within 12 months of the US patent filing.
Sucks, but that is the way the game is played.
Your patent, however, might inspire a partner/investor with deep pockets who could front the cost of the additional patents.
The patents should help protect your application as long as the competitors don't have really deep pockets to afford to attack you. And you could also use the patent to license the application TO your "competitors."
In rare instances class III devices are downgraded to class II. In addition some class III devices can be approved based on 510K, but their number is exceptionally low. It will probably never happen after only one device is approved. In terms of the trial design for this new company - I doubt that they will want to compete against the only one approved device. Usually for the first few devices of a new class the design will be based on the comparison with previous generation/clinical approach. Only after a number of the devices are approved, the new comers will be asked to do the comparison to one of them. See coronary DES approval history.
I generally agree with what my colleagues above have said on this topic. If the device in question is unclassified (no regulation number) then either submit a de novo request for Class II designation or simply file your 510(k) and seek a response (either SE or NSE). A Presubmission Meeting is advisable if unclassified.
If the device is currently classified (with regulation number) then a request for down classification is one approach. FDA is now 75% through its own Reclassification Initiative (see link) and Data Reduction per recent changes in the FD&C Act. This offers a viable avenue to lower your data requirement and reduce regulatory burden.
http://www.fda.gov/RegulatoryInformation/Guidances/ucm073707.htm
https://www.federalregister.gov/articles/2015/04/29/2015-09884/retrospective-review-of-premarket-approval-application-devices-striking-the-balance-between
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