ARTICLE
6 January 2020

FDA Identifies Medical Devices And Systems Exempt From Premarket Notification Requirements

DM
Duane Morris LLP

Contributor

Duane Morris LLP, a law firm with more than 800 attorneys in offices across the United States and internationally, is asked by a broad array of clients to provide innovative solutions to today's legal and business challenges.
Before a medical device is brought to market, the FDA requires a premarket submission. For low risk devices, that submission is often via a 510(k)
United States Food, Drugs, Healthcare, Life Sciences

Before a medical device is brought to market, the FDA requires a premarket submission. For low risk devices, that submission is often via a 510(k), demonstrating that the device is at least as safe and effective as (substantially equivalent to) an already legally marketed device that is not subject to premarket approval.

As of December 30, 2019, certain Class I and Class II medical devices and systems that previously required a 510(k) submission are now, based on certain criteria detailed in the FDA's rule, exempt from that requirement. The regulatory adjustment will mean that the dozens of medical devices and test systems identified will no longer have to comply with the premarket clearance, subject to certain conditions.

For example, among the impacted items are numerous drug detection systems, such as amphetamine test systems, barbiturate test systems, benzodiazepine test systems, codeine test systems, and methamphetamine test systems, all of which are exempt unless they are intended for any other use than employment, insurance, or federal drug testing programs. The new rule also affects other categories of devices and tests, such as unscented menstrual pads, assisted reproduction accessories and microtools, and breath-alcohol test systems.

Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.

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