Memorandum to the President of the United States From: Hooman Noorchashm MD, PhD Re: Severe Patient Safety Deficit in the Food and Drug Administration’s 510(k) Provision The safety and efficacy of medical devices used for the care of patients in the United States is critical for the protection of public health. The Food and Drug Administration under the 1976 amendment to the Food, Drug and Cosmetics Act is responsible for clearance of medical devices for marketing. The 1976 amendment included a premarket approval (PMA) process for devices that is similar to the new drug application process. The PMA is a specific legal mandate for safety testing of medical devices. In 1976, many devices were already in the marketplace. Therefore, Congress included an alternative pathway to the PMA, known as 510(k). This provision aimed to provide a less burdensome route to facilitate access of newer versions of existing devices to the marketplace. Importantly, the 510(k) pathway did not require clinical trials or manufacturing inspections to demonstrate device safety. With the advent of the Medical Device User Fee and Modernization Act in 2002 (MDUFMA), the FDA was guided to shift its regulatory standard to “the least burdensome approach in all areas of medical device regulation.” As a result, FDA currently authorizes the marketing of the majority of medical devices via the 510(k) pathway. Functionally, this shift guaranteed that the vast majority of FDA authorized medical devices in the United States are not safety tested. Moreover, the 510(k) pathway does not provide an enforceable post-market surveillance or reporting mechanism to FDA. In 2011, as a result of several emerging safety concerns, the Institute of Medicine analyzed the 510(k) provision and concluded in formal testimony to the United States Senate’s HELP committee that it “does not and can not ensure patient safety”. For complex reasons, congress elected to maintain the 510(k) provision and did not revise it. In December 2013, the Wall Street Journal recognized and reported that an FDA authorized medical device known as a “power morcellator”, and widely used by gynecological surgeons in the US and abroad, was responsible for spreading and upstaging aggressive cancers in one in 350 American women undergoing hysterectomy. Many American families, for over 2 decades, have been irreversibly harmed as a result. The FDA has confirmed that this deadly hazard was masked from agency regulators until December 2013. Investigative reporting by the WSJ subsequently demonstrated that the “morcellator disaster” was, in great part, caused by the safety failure in FDA’s 510(k) provision. The power morcellator case is a bellwether case for medical device safety in the United States. It demonstrates the need for immediate reform of the 510(k) provision to ensure the safety of American patients. This memo is to inform the President of a severe safety deficit in the legislation governing medical device authorization by FDA. This danger to public health is clear and present. It is, therefore, recommended that the president immediately call for and support a revision to the 510(k) law that would: 1) more stringently define medical devises eligible for authorization via the 510(k) pathway and 2) include an effective and enforceable post-market surveillance and reporting mechanism for detection of adverse outcomes associated with the use of medical devices in the United States.
Posted on: Thu, 01 Jan 2015 23:01:01 +0000
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