The US FDA made an official announcement (FDA Update in December 2018) that they intend to “supplant the existing requirements with … ISO 13485:2016.” According to the FDA, they are taking these steps in order “to harmonize and modernize the Quality System Regulation for medical devices.” They also stated that they are doing so to “reduce compliance and record keeping burdens on device manufactures.” Let’s break that down a bit and explore some underlying assumptions in those statements.
To many in the industry, this announcement was great news but let’s take a look at some of the underlying assumptions that may well do more harm than good for US medical device manufacturers and consumers alike. In the next post, we will continue the discussion by breaking down some real-life barriers that might slow or prevent it from happening at all and why that might not be a bad thing.
First, there is an underlying assumption that the “compliance burden” on device manufacturers is currently too great a burden to bear. Now, for those of us working in device manufacturing facilities every day, this admission is somewhat of a surprise.
Literally, every guidance document produced by the FDA for almost two decades has stated a “least burdensome approach” when developing such documents. I think it’s fair to ask if this new revelation by the agency now calls into question the thousands of guidance documents written to date and published by the FDA as the “least burdensome?”
How will this impact the existing quality systems of manufacturers that were developed with these least
burdensome approaches in mind? Also, what does the FDA mean exactly when they coin the generic phrase “compliance burden?” There are certainly many “compliance burdens” currently required and enforced by the FDA that are not part of the Quality System Regulation at all, and, I would argue, a much greater burden on manufacturers than the Quality System Regulation itself.
Why is the sole focus of this effort with the Quality System Regulation?
Why are we not looking to spend our tax dollars on modernizing and streamlining the significantly burdensome processes for market access (510k, PMA, De Novo, LDT’s, clinical data requirements, etc.)?
Another question worth asking is how does adopting a Standard written by and for EU member states (of which the US is not a member) benefit the safety and effectiveness of products distributed within the United States?
The answer is likely that the US will need to retain many, if not all, of the requirements currently in place to continue to ensure the level of safety and effectiveness that our consumers currently enjoy.
Second, there is an underlying assumption that the “record keeping burden” on device manufacturers is currently too great a burden to bear. It would be helpful if the FDA could pinpoint and communicate which record keeping requirements they see as too burdensome and; more importantly, how adopting ISO 13485:2016 will reduce that burden. ISO 13485:2016 is certainly not devoid of record keeping requirements related to the outputs from processes required to comply with the Standard (already significantly harmonized with the FDA process and record keeping requirements).
Additional to that, the prominent phrase throughout ISO 13485:2016 is that manufacturers must comply with “regulatory requirements” for the countries within which their devices are distributed. Record keeping and reporting burdens are often found within those local, regional, and country-specific regulatory frameworks and are largely not detailed in the ISO framework.
It is easy for the medical device industry to jump on the bandwagon when we hear catch-phrases from the FDA like “reduce compliance burden” and “reduce record keeping burden” but until we know exactly which burdens they intent to reduce and how adopting ISO 13485:2016 will specifically reduce them, caution should be in order here. We may just find ourselves in a more burdensome position in the future by handing over the control of our own regulatory framework to an EU controlled process which, by all indications with the new EU MDR, is moving toward a more burdensome approach.
Stay tuned for our next post where we will explore some of the specific barriers that will slow, if not halt, supplanting the QSR with ISO 13485:2016. We will also continue to discuss why this new direction may not be in the best interest of US manufacturers or consumers.
Thoughts? Please comment below....