It has been over a decade since my late-wife, Dr. Amy Josephine Reed, was harmed and killed by a poorly regulated medical device, known as the Power Morcellator. The sheer force of Dr. Reed’s voice, as a Harvard Medical School faculty member and a physician-scientist — and the injustice it uncovered to countless other women like her — became a bellwether case that demonstrates an ongoing and severe safety failure operational in the medical device regulatory space at FDA.
Of course, this safety failure in the FDA’s medical device regulatory arm, the Center for Devices and Radiological Health (CDRH), is hardly unique to that center. Industry and conflicted academic “experts,” not patients, play an outsized role in governing and corrupting almost all of the FDA’s centers. But, certainly, the source of the safety failure at CDRH is crystallized in the dangerous regulatory regime that the agency center utilizes to clear the vast majority of medical devices for the US healthcare marketplace: The 510(k).
At a legislative level, CDRH’s 510(k) regulatory regime was not designed to ensure the safety or efficacy of the medical devices it regulates — a fact that is well known to most public health experts and FDA regulators themselves. CDRH’s 510(k) does not use anything even remotely resembling an “evidence-based” framework to provide clearance to thousands of new medical devices annually used in the care of patients across the US and abroad.
Even more problematic is that the medical device industry pays the FDA for the 510(k) clearances obtained. In other words, almost the entire 510(k) clearance apparatus at CDRH is literally funded by the medical device industry — the very industry that stands to gain the most from the 510(k) clearances it funds. This is a serious conflict of interest in the healthcare space, and should not pass ethical muster — even when the argument is that such payments from industry to government are saving taxpayer dollars. The moment the industry starts paying to keep the FDA’s centers’ lights on is when the industry, not the people, will have an outsized voice in governing the agency that is regulating it.
Worse yet, the CDRH personnel whose 510(k)-related activities are funded by medical device makers exert virtually no real scrutiny over the manufacturer’s claims in their 510(k) applications for market clearance — either because their “reviews” are deliberately superficial and nominal, or because they are grossly incompetent from an expert perspective. It is literally true that the overwhelming majority of medical devices that seek 510(k) clearance for use in the US marketplace are granted them, without difficulty and at mach speed, by any reasonable standard — and although these devices are literally directly engaging the most vulnerable of America’s citizens: patients who trust American healthcare at their most vulnerable!
Hellbound and Down 