Yes. Rob is.

John, visit Rob's site at MedicalDeviceAcademy.com for lots more good stuff!

For PEEK, the material is not FDA approved. The FDA doesn't approve materials. In fact, they also don't refer to the 510(k) as approval. Technical a 510(k) is pre-market notification, and a PMA is pre-market approval. PMAs are required for high-risk implants, and 510(k) submissions are required for moderate risk devices with similar "predicate" devices that are already on the market. In this case, you have described, a 510(k) is required for patient-matched implants. You generally do your validation using a worst-case example of the smallest or largest possible implant (e.g. 120% of someone my size - 2 meters tall and 135 kg). Hospitals that are making implants are typically doing this as part of research. The only big difference between the production of a patient-matched implant and batches of implants, is the lot size is 1 instead of many and the labeling includes a patient ID #. Both batches and patient-matched implants can have serial numbers, but only a patient-matched implant will have a patient ID # on the label. I have also seen a few companies make a spare implant for patient-matched implants, because if the original is dropped they need a spare

@@MedicalDeviceAcademy Thank you. My husband emailed Rob Packard, and he got a very similar answer. Is this Rob?

@@casade2831 Yes, one and the same...but this post posted on Joe's KZfaq channel where we are both commenting.

The FDA guidance for biocompatibility covers this topic in detail: www.fda.gov/media/85865/download. Material certifications are never enough by themselves, because you need to consider the impact of all the manufacturing processes on the finished device. The reason for this is that there may be residuals or contaminants from the manufacturing process that could negatively affect biocompatibility. For example, if you are currently making a molded part at one facility, you need to do additional biocompatibility testing if you change to a different molding facility. If you can show that there are no new residuals or contaminants from the new molding process, then you might be able to provide a biocompatibility risk assessment with limited testing data. Differences in raw materials are important, because plastics will include plasticizers and additives that may not be obvious but the same is true for metals that have different cleaning and passivation processes. Unless you have a raw material specification that a competitor used AND you know exactly what the manufacturing process was, your justification for not doing testing will not be adequate.

@@MedicalDeviceAcademy What you say makes perfect sense. Thank you for taking the time to respond.