• What findings did you have in your last FDA inspection?
• What findings have your internal audits produced over the past 24 months?
• How many open Corrective and Preventive Actions (CAPAs) do you have? What are they?
• How long on average are your CAPAs open?
Submissions to and clearances from FDA The regulatory and engineering process of preparing an FDA submission is time-consuming and expensive. But the reprocessor should not cut any corners. Once again, the reprocessor’s standards should be higher than an original device manufacturer. Consider “the n+1 rule”: If the reprocessor asks to reprocess a device twice for a total of 3 uses, the company must provide data that shows device integrity after three reprocessing cycles (2+1). If devices in transport could be exposed to temperatures of 100 degrees for 24 hours, the reprocessor should put them in the oven at 150 degrees for 48 hours; if maximum strength put on a handle in a procedure is 20 pounds, the reprocessor should test the device at 40 pounds, etc.
One of the things that sets reprocessed devices apart from new ones is that every single device is tested (numerous times) during the reprocessing process. Original manufacturers do not do this. This means that physicians can have a high degree of confidence that the device will work. This is a core principle of reprocessing that should never be challenged.
In an FDA submission, transparency and data integrity is important. The reprocessor should only apply for the products and brands that data supports. The rule is that you cannot include two devices in a submission that have different indications or material design/functionality differences. There have, recently, been situations where clearances have come very easily to new reprocessors, and it could be speculated that “creative” work is the cause. And when the reprocessor utilizes its clearance, you should expect them to be conservative about what devices they consider to fall under that clearance.
Medical device manufacturers and reprocessors use a regulatory pathway called “line extensions” to be able to market devices that may not have received a clearance but are so similar that they can be “folded in” under a previously received clearance. This is dangerous territory, and the practice should be conducted very diligently. Again, from a regulatory standpoint, this is only permissible if the device has the same indication and is materially and functionally similar to the predicate device.
