-
ih37 replied to the topic Discussion Topic: Revamping the 510(k) Process in the forum Regulatory Basics for Medical Devices 6 years, 6 months ago
The article posted with this week’s lecture: “Medical Devices and the Public’s Health” by the Institute of Medicine (IOC), gives an overview of the IOC’s perspective on the 510(k) process over the past 35 years. The IOC points out that for a medical device of a moderate risk to enter market, it must prove substantial equivalence to a predicate device that was on the market before the Medical Device Amendments of 1976. This leads the FDA to believe that any medical device that proves substantial equivalence is safe and effective enough to not require any inspection or investigating since they are believed to follow the same design as these predicate devices with market success. This draws concern from the IOC since devices that were on the market before 1976 were never “systematically assessed for safety and effectiveness – but they are being used as predicate devices”. The main reason the IOC believes that this regulation flaw has been overlooked is because the consistent use of these predicate devices in clinical settings have shown enough success to the point that any further examination of their safety/efficacy will be viewed by the FDA as redundant. The IOC concludes by bringing the concept of pre- and postmarket regulatory surveillance to attention.
One surveillance technique mentioned in another IOC article (1) is to allow the FDA to regulate the labeling of a drug product after its market release (to immediately relabel any adverse effects found postmarket). Other techniques mention the distribution of medical devices only to facilities that have been specifically trained to specialize in that medical device itself rather than to any physician, reducing the likelihood of the device being misused (while also reducing the revenue generated by the device). A final important regulatory technique requires medical device companies to have an “active adverse event surveillance system”, such as an online link easily accessible by patients and specialists to direct their complications and concerns. All of these techniques require a monetary investment by the medical device companies, which some companies deliberately do not do because, according to Dr. Simon’s Orthopedics course, the cost of losing a lawsuit is less than implementing such regulatory measures.
