Basically is breakthrough device designation for an intended use claim ? or is the designation tied to the device? I suspect the latter, but just wanted to ask.
So to clarify. Let's say I (the manufacturer) have a device with an intended use claim and have identified a predicate device on the market (similar technology and intended use claim). I would then submit for 510K clearance.
After 510K clearance is granted (hypothetically), I decide to add a NEW intended use claim that my predicate device does not have, and no predicate with a similar intended use can be found. Also, I have not made any design changes to my device since it gained 510K clearance despite the fact I plan on adding a new intended use claim to it.
Would I be eligible to get a Breakthrough Device designation for this new claim for a device that already received 510k under a different intended use claim?
The thought process here is getting the initial 510K clearance for to become more attractive to investors, then Breakthrroughh device designation to achieve the automatic 65% reimbursement from CMS via new technology payment (NTAP) and or TCET pathway.
So to clarify. Let's say I (the manufacturer) have a device with an intended use claim and have identified a predicate device on the market (similar technology and intended use claim). I would then submit for 510K clearance.
After 510K clearance is granted (hypothetically), I decide to add a NEW intended use claim that my predicate device does not have, and no predicate with a similar intended use can be found. Also, I have not made any design changes to my device since it gained 510K clearance despite the fact I plan on adding a new intended use claim to it.
Would I be eligible to get a Breakthrough Device designation for this new claim for a device that already received 510k under a different intended use claim?
The thought process here is getting the initial 510K clearance for to become more attractive to investors, then Breakthrroughh device designation to achieve the automatic 65% reimbursement from CMS via new technology payment (NTAP) and or TCET pathway.
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