Summary

On March 13, 2017, the U.S. Food and Drug Administration (FDA or the Agency) identified a list of 1,003 types of Class II medical devices that, when finalized, will be exempt from the Agency’s premarket notification (i.e., 510(k)) requirements, subject to certain limitations. This is the first time since 2015 that FDA has exempted medical devices from 510(k) review, although previous exemption announcements covered far fewer device types than this sweeping deregulatory action. This is also the Agency’s first notice regarding medical devices that no longer require 510(k)s that it is required to publish pursuant to the 21st Century Cures Act.¹

By way of background, a 510(k) is a premarket submission made to FDA to demonstrate that the medical device to be marketed is at least as safe and effective (i.e., substantially equivalent) to a legally marketed device (i.e., predicate). Each person who wants to market in the United States (U.S.) a Class I, II, or III device intended for human use, for which a premarket approval (PMA) is not required, must submit a 510(k), unless the device is 510(k)-exempt.

Per the Agency’s March 13th notice, devices for which 510(k)s will no longer be required range from DNA genetic analyzers to certain compression garments to umbilical clamps to biopsy needle guide kits to some hearing aid selection and calibration tools, and many devices in between. While these and certain other devices will no longer require 510(k)s, they will still be subject to regulatory controls. More specifically, such devices must be: manufactured according to current good manufacturing practice (CGMP) requirements, as set forth in FDA’s Quality System Regulation (QSR); suitable for their intended use; and adequately packaged and properly labeled. In addition, owners or operators of businesses that are involved in the production and distribution of medical devices intended for use in the U.S. must register annually with FDA and must list their devices with the Agency.

As any medical device company that has gone through the development and submission of a 510(k)can attest, the process can be labor intensive, time consuming, and expensive. In 2015, the Agency reported that average time to decision on 510(k) submissions was 95 days, compared to 126 days in 2014. Moreover, in addition to the costs involved in developing a medical device and preparing a 510(k), there is a filing fee associated with the submission. The Fiscal Year (FY) 2017 fee is $4,690, or $2,345 for certain small businesses. Accordingly, FDA’s decision to exempt from its 510(k) requirements a broad array of Class II medical devices is a significant boon to companies looking to market such devices.

1. On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Pub. L. 114-255). Section 3054 of the 21st Century Cures Act, which amended section 510(m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act), requires FDA to publish in the Federal Register a notice containing a list of each type of class II device that FDA determines no longer requires a 510(k) submission to provide reasonable assurance of safety and effectiveness. Per the 21st Century Cures Act, FDA is required to publish this notice within 90 days of the date of enactment of the 21st Century Cures Act and at least once every five years thereafter, as FDA determines appropriate. Additionally, the Agency must provide at least a 60-day comment period for any such notice.