The Food and Drug Administration (FDA) has expanded its accelerated approval process for medical devices to include end-stage renal-disease devices. Three out of 32 applicants were selected to be among the first to qualify for the program.
The accelerated approval process for medical devices has allowed much-needed medical devices on the market without clinical testing if they are similar to ones already on the market. But the process has come under fire in recent months because of injuries and recalls on devices that critics say were cleared before safety and efficacy were established.
Earlier this month, Consumer Reports urged Congress to strengthen its oversight on medical devices, citing serious injuries caused by devices like artificial hips, and transvaginal mesh used in pelvic organ prolapse and urinary incontinence repairs that were initially approved under the expedited process.
The three new products to be considered for FDA’s sped-up approval are an implantable renal assist device developed by the University of California at San Francisco; a wearable artificial kidney by Blood Purifications Technologies of Beverly Hills, Calif.; and the Hemoaccess Valve System, designed by Greenville, S.C.-based CreatiVasc Medical.
Advanced kidney disease technology became a focus for the FDA because the condition affects more than a half a million Americans. It cost Medicare more than $29 billion in 2009.
The medical device industry applauds the FDA’s decision to speed up approval of devices for advanced kidney disease, expressing in a statement that early interaction between device developers and the agency can be critical in speeding innovative technology through the FDA review process and into the hands of physicians and patients.
Source: Modern Healthcare