Over three-hundred class II medical devices made the list of those that might become exempt from premarket notification requirements once the FDA takes final action.
The Food and Drug Administration March 14 published a proposed list of class II devices that will be exempt from the requirements, also called 510(k)s, when the list is made final (82 Fed. Reg. 13,609). Class II devices are moderate-risk devices. A 510(k) clearance demonstrates that a device is substantially equivalent to another (or predicate) device already on the market. Clinical data typically aren’t generated for a 510(k).
The 21st Century Cures Act (Pub. L. No. 114-255), a 2016 law to speed new drugs and devices to market, required the FDA to publish the list. The FDA said the final list will decrease regulatory burdens on the industry by eliminating time and resources needed to submit 510(k) notifications. The devices include dentures, umbilical clamps, obstetrical forceps and surgical clamps.
Comments on the list are due May 15 (Docket No. FDA-2017-N-1129). The agency said it will consider the comments and determine whether the list should be modified before publishing the final version.
The National Center for Health Research, a nonprofit that encourages new and more effective medical treatments, is concerned these devices won’t be reviewed by the FDA.
“We are very concerned about this huge list of devices that will no longer go through any kind of FDA review,” Diana Zuckerman, president of the nonprofit, told Bloomberg BNA in a March 20 email. “The FDA’s faulty justification is that the FDA already knows quite a bit about these devices, but that ignores the fact that when a new company starts making a device, or when any company makes changes to a device, the device can become substantially less safe or substantially less effective, or both.”
Zuckerman said “it is very disturbing that the FDA’s Center for Devices is so focused on relieving device companies of the burden of providing evidence of safety and effectiveness, but not at all concerned that now doctors and patients have an impossible burden of trying to figure out which devices they can rely on and which they can’t. And if we are ever going to have a value-based reimbursement system for medical care, increasingly devices will not be covered because so often there is no scientific evidence that a specific device will benefit patients.”
List Longer Than Expected
Bradley Merrill Thompson, a Washington-based attorney with Epstein Becker & Green PC, told Bloomberg BNA in a March 20 email the FDA’s list is longer than he expected, which is good news because he was afraid the FDA would exempt just a few categories of medical devices. Thompson counsels medical device, drug and combination-product companies on a wide range of FDA issues. He’s also a Bloomberg BNA health-care advisory board member.
“The proposed list is pretty comprehensive, covering most areas of medical devices,” Thompson said. “The purpose of this exercise is both to save industry resources developing unnecessary premarket submissions, but also to conserve agency resources for those products that really need oversight.”
Thompson said the list “will help FDA focus its attention on those technologies that really need premarket review.”
The Advanced Medical Technology Association (AdvaMed) “is still reviewing FDA’s proposed 510(k) exemption list,” Janet Trunzo, senior executive vice president, technology and regulatory affairs at AdvaMed, said in a March 20 statement provided to Bloomberg BNA. “We commend the agency’s progress in implementing this important provision of the 21st Century Cures Act, which supports a risk-based review approach by creating a regular process for identifying lower-risk products appropriate for exemption.”
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