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, among others, dentures, umbilical clamps, obstetrical forceps and surgical clamps.
“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 me. “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.”
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.
Read my full article here.
Stay on top of new developments in health law and regulation with a free trial to the Health Law Resource Center.
Learn more about Bloomberg Law and sign up for a free trial.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to firstname.lastname@example.org.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to email@example.com.
Put me on standing order
Notify me when new releases are available (no standing order will be created)