Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years

Medical gadgets which can be deemed to have a reasonable threat to sufferers usually can not go available on the market till they’re cleared by way of the FDA 510(ok) course of. Lately, people and organizations have expressed concern that the 510(ok) course of is neither making secure and efficient gadgets out there to sufferers nor selling innovation within the medical-device trade. A number of high-profile mass-media stories and consumer-protection teams have profiled acknowledged or potential issues with medical gadgets cleared by way of the 510(ok) clearance course of. The medical-device trade and a few sufferers have asserted that the method has turn into too burdensome and is delaying or stalling the entry of necessary new medical gadgets to the market.

On the request of the FDA, the Institute of Medication (IOM) examined the 510(ok) course of. Medical Gadgets and the Public’s Well being examines the present 510(ok) clearance course of and whether or not it optimally protects sufferers and promotes innovation in assist of public well being. It additionally identifies legislative, regulatory, or administrative adjustments that can obtain the targets of the 510(ok) clearance course of. Medical Gadgets and the Public’s Well being recommends that the U.S. Meals and Drug Administration collect the data wanted to develop a brand new regulatory framework to exchange the 35-year-old 510(ok) clearance course of for medical gadgets. In line with the report, the FDA’s finite assets are finest invested in creating an built-in premarket and postmarket regulatory framework.

Writer ‏ : ‎ Nationwide Academies Press; 1st version (November 25, 2011)
Language ‏ : ‎ English
Paperback ‏ : ‎ 318 pages
ISBN-10 ‏ : ‎ 0309212421
ISBN-13 ‏ : ‎ 978-0309212427
Merchandise Weight ‏ : ‎ 1.14 kilos
Dimensions ‏ : ‎ 6 x 0.9 x 8.9 inches