The regulatory environment has clamped down in the USA in recent years. The FDA is ramping up its efforts in the medical device space, and the requirements are rapidly changing, and in most cases, increasing.
Take for example the 510k process. For many years, it was common practice to use multiple predicates to show substantial equivalency. That is no longer a method the FDA is in favor of seeing. Instead, they want a single predicate, and data to mitigate risks that fall outside of equivalence with that single predicate device.
Clinical data requirements for medical devices are generally not well defined by the FDA, at least not publicly. Instead, it falls upon the filing party to present sufficient data (in its own estimation) with enough statistical significance to satisfy the requirements. Occasionally a filed 510k may get a reviewer that is willing to help guide clinical data collection, but as a corporate strategy, it isn’t safe to rely on it.
Getting past the hurdles of properly filing the required documents and having your application accepted are only the minimum steps required to gain approval. If your goal is to be approved without further clarifying submissions at their request, your plan needs to be comprehensive in scope and scale. Even then, the FDA may find reason to question your claims beyond what you anticipate.
Take for example a recent 510k filing by EMCI. Our application was complete and accurate, and in line with what predicate filings for the device class had used. However, the FDA had just gotten a smattering of adverse events from a product with the same device class… thus, they required us to go back and perform additional clinical trials to mitigate this newly-discovered risk. Had we filed the identical 510k three months earlier, very likely it would have been approved without any additional data.
We have regulatory experts and ex-FDA reviewers at our disposal to use as a resource, and still, we are often surprised by the particular claim that sticks out to the FDA. The key to keep in mind is that once they request information the clock is ticking. If you can’t collect the necessary data before the application expires, you’ll have to refile from scratch, with no guarantee that you will get the same reviewer. A new reviewer may have completely different information requests, and the process can become a vicious circle without careful planning.
The FDA’s role in keeping a lid on unsafe drugs and devices is incredibly important. Indeed, as a device company our goals are not at odds with those of the FDA. We want to provide human health advancing technologies without introducing any unexpected consequences for the patient or physician. It’s a goal we share with those that regulate us.
The information provided through this blog is not a substitute for legal, regulatory or other professional advice where the facts and circumstances warrant. If anyone in your organization requires legal, regulatory advice or other professional assistance, they should always consult his or her own legal, regulatory, or other professional advisers and discuss the facts and circumstances that apply to their specific project.