I’ve been working in regulatory for a company in which biocompatibility of device materials has been pretty straightforward and understood by all for many years. Annex A in ISO 10993-1 and FDA General Program Memorandum - #G95-1 is all you need. Check the chart for our device intended use and see that irritation testing, sensitization testing and cytotoxicity testing are required for any new device materials prior to introducing them into the market. Not only did our regulatory folks clearly understand these requirements, but our project teams were also onboard. If engineering wanted to change materials or change the material color or tint, they would contact a toxicologist to perform these three necessary tests. End of story.

Then, BAM! About two months ago, during a 510(k) review, the FDA requested implantation testing and genotoxicity testing for any new materials that we were using. This threw us all for a loop. Not only would project timing be impacted by this requirement for more testing, but also our wallets were going to take a hit. As regulatory specialists, we tried to defend our case and continue with the biocompatibility approach that we have become accustomed to and which had been cleared for many years. We failed. Now comes the tough part…..telling our project teams this guidance that we have received from FDA.

Like anything new that comes into the regulatory world, the project teams believe that their beloved regulatory specialists have come up with these new requirements all on their own. Obviously, we all know this not the case. We are driven by regulatory requirements and guidance documents. These biocompatibility changes have not been easy. I have sat through many meetings over the past two months in which team members have tried to coerce me into changing my mind on performing implantation and genotoxicity testing for new materials - as if I have any say into what the FDA wants from us. Two weeks ago, I gave up in the middle of a conference call because I just couldn’t take the constant battle. Believe me, we all want to sail through a project with no hiccups. Your regulatory professional is not trying to cause more headaches.

Unfortunately, changes come about through the agency that we all have to adapt to, learn from and move on. We can’t continue to fight or our new medical devices will never get to market. I have heard that within the industry we are not the only ones dealing with biocompatibility changes. Anyone else feeling this pain? This bit of industry news still doesn’t make our project teams feel any better about the additional testing.

I was in a team meeting last week and the project manager announced that engineering was considering a new material for one component of the device. I visibly began to squirm in my seat. He followed up with “and we are sending the material to have biocompatibility testing completed, including implantation testing and genotoxicity testing.” I almost lunged across the table to hug him. Instead, I politely said “Thank you”. Have they finally caught on?

- Deb Gimbel

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