Require safety testing for medical devices

The FDA does not require safety testing for many medical devices before they are allowed onto the market. This is due to the 510(k) loophole – a regulatory gap in the FDA’s medical device approval process. This loophole allows medical devices to be cleared for market entry without clinical trials or rigorous testing, as long as the device in question is deemed “substantially equivalent” to an already approved device. This allows for a pyramid scheme of sorts (similar to what exists currently for vaccines being tested against other approved vaccines in order to establish safety), whereby an unsafe medical device can act as a predicate device for a similarly unsafe device to be allowed onto the market, without adequate testing or clinical trials to establish safety.

The 510(k) loophole has led to the marketing of medical devices that were later found to be harmful, resulting in patient injuries and deaths. Gynecological (transvaginal) mesh for POP (pelvic organ prolapse) or SUI (stress urinary incontinence) would be but one example of the serious harm that has resulted from the FDA’s industry-friendly 510(k) regulatory loophole. To safeguard the health of people, the FDA needs to require safety testing for moderate risk medical devices.

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