Submitting a PMA is a lot of work, no question about it. But there's a sense in the IVD world that getting a Class III PMA finding is the "kiss of death" for an early-stage project. I think the fear of PMAs is a bit overblown.
To some degree, this sensitivity starts with IVD investors. PMAs are more work than 510(k)s and create longer lead times. Longer lead times mean increased time to achieve ROI. PMAs aren't a sure thing, either. We've all heard stories about PMAs that spawned years of review and back-and-forth with FDA. Some of those stories are even true.
What the fear obscures, however, is that the amount of work you need to do for a PMA is not very much larger than the amount you are supposed to do for a 510(k). The major differences are:
- FDA actually checks your process before you get on the market instead of giving you the benefit of the doubt
- FDA has identified your product as "high risk" and is therefore going to be careful, deliberate and thorough in reviewing your application
- FDA will want to review the justification for most after market changes (design changes, process changes, etc)
When it really comes down to it, a PMA requires that you prove your product is manufactured appropriately instead of simply raising your hand and swearing under oath that it is. For some of us, there may be a world of difference between what we swear we do and what we actually do. But the companies we work with know they're going to get audited eventually anyway and there's not a long-term benefit to abusing FDA's trust.
It's tempting to think of a 510(k) as a shortcut, a way to get on the market sooner and you'll just figure out the difficult details later after the cash comes in. Or, more to the point, somebody else will figure out the details after you've already cashed out. Skipping the hard stuff might make you look like a rock star now, but success built this way is likely to be short-term.
We're not frightened of PMAs because we take 510(k)s seriously enough to make sure they pass muster in the long run. There's no reason a IVD company shouldn't be able to approach a PMA if it has the right kind of planning, strategy, design control, quality systems and leadership. You might be headed to the CLIA or research market first, but the plans you lay now may determine if a PMA will elude your grasp in the future.
PMAs aren't the kiss of death. Lack of planning is the kiss of death. PMAs are simply the instrument by which many companies discover that they have failed to plan appropriately.