Pre-Check for Medical Devices? Considerations for the FDA's new software pipeline

As medical technology becomes more sophisticated, the future of medicine seems increasingly uncertain. Diagnostic machinery and medical devices already dominate modern hospitals, suggesting that the future of healthcare will depend on the development and adoption of new technology.  Thus, understanding the pipeline responsible for the approval of new medical devices is essential to predicting the future of healthcare.

Currently, all medical devices on the market must first be filed with a 510(k) at the Food and Drug Administration (FDA), clearing them for sale in the United States. Companies must repeat this filing process each time they change the hardware or software that they sell. Lengthy and bureaucratic though it may seem, this regulatory process serves as an important barrier against the sale of unsafe medical devices.

However, in light of the recent surge of sophisticated medical devices, the FDA is considering overhauling its current 510 protocol for medical software. Agency officials cite the fact that software manufacturers often release updates and patches every few weeks, while the average time for receiving 510 approval in 2016 was 117 days—over 3 months. Furthermore, newer medical devices containing artificial intelligence must be updated by hand to integrate new training data for the machine. Unlike the artificial intelligences that operates Siri or Netflix, which are trained on a continuously updated archive of user interactions, AI in medicine must be fed carefully curated data to prevent it from yielding potentially disastrous diagnoses. This is especially true for computer assisted diagnostic devices, like IBM’s Watson for Oncology, which are already aiding doctors in assessing difficult cases. 

The FDA’s  new approach, which is meant to streamline the approval process for medical devices containing AI, would significantly cut down on the approval wait time by giving special privileges to companies which have a “culture of quality and organizational excellence.” In effect, the new program functions like TSA Pre-check, but for massive pharmaceutical giants. Companies will be able to request an “Excellence Appraisal,” a background check that assesses an organization’s history of good safety practices. Once these manufacturers demonstrate qualities like “clinical responsibility” and a “proactive culture”, they will be able to send out updates with very little interference by the FDA. During a press release in January 2019, FDA officials stated that the organizations that fit this profile “not only do the right things”, but also “do the things right,” implying that approved companies must have internal checks that are rigorous enough to warrant the present and future trust of the FDA. 

The planned changes come after a barrage of scrutiny in November 2018 over the FDA’s existing expedited review process, which allows companies to release changes to medical devices by producing evidence of similarity to older devices. Critics pointed to cases where failed medical devices were approved using comparisons to devices more than 30 years old, some of which are not even on the market today. The FDA is responding to the current administration’s pressure to enact regulations which “encourage industry to act” (CNBC). 

While the FDA’s reform process might seem like a step towards a future in which the government can keep pace with rapid innovation, speed often comes at the expense of accuracy. The FDA’s implementation of a “hands-off” methodology seems dangerously reminiscent of the policies that led to the recent Boeing MAX-8 scandal, which was partially caused by the Federal Aviation Association decision to “trust” companies like Boeing to essentially regulate themselves. Whereas the MAX-8 scandal has already caused the tragic loss of hundreds of lives, the FDA now holds lives and health of millions more in its hands. Even a single misstep in this high-stakes game could be catastrophic. 

In our rapidly advancing society, the government must maintain a difficult balance between enabling innovation and upholding safety standards. With this overhaul, the FDA is attempting to contend with the “move fast and break things” mentality that pervades Silicon Valley, but it may be giving companies too much leeway, setting up the medical devices industry for a costly mistake. As this story unfolds, the FDA would be wise to be cautious as it handles the growing influence of artificial intelligence over the health of the American people.