IOM report is a step backwards for medical device companies
The medical device industry has been complaining for years about the extended review time for 510(k) FDA approvals. The Institute of Medicine (IOM) released its FDA commissioned report Friday, which recommended discarding the 510(k) process and replacing it with a more scientific approach. So, why is the medtech industry up in arms?
The IOM report correctly concluded that the 510(k) process is not scientific. Unfortunately, the strength of regulatory bureaucrats is not science but precedent, which is why the 510(k) process, with its focus on predicate devices, works reasonably effectively.
The IOM concluded, “the 510(k) process lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk devices and, furthermore, that it cannot be transformed into one.” Although it’s short on specifics, the IOM review suggests that the FDA explore whether a modified version of its Pre-market Approval (PMA) process could replace the 510(k) process.
To earn 510(k) approval, device companies seeking approval for a low-to-moderate risk device must prove that the device is substantially similar to another device already on the market. Unlike the premarket approval process — which is used for brand-new devices and high-risk devices — a company usually does not need to provide clinical data to support its contention that its medical device is safe and effective.
The current PMA process has no predictability or transparency, and reminds me of Mr. Toad’s wild ride at Disney World. Medical device companies should rightfully be concerned that the PMA process needs overhaul before the 510(k) process can adapt its ways.
Despite the fact that certain predicate devices were never actually approved but grandfathered in and a small number of cleared devices have stretched the spirit of the 510(k) process, the 510(k) approach has been successful due to its predictability and consistency. The same cannot be said for the PMA process.
In the end, the IOM report is technically and theoretically correct, but realistically a step backwards for medical device companies. An approach that deals with the realities of the FDA resources and culture, which the FDA has embarked upon, is to provide better guidelines for determining which minority of devices require additional clinical data to support 510(k) clearance.