FDA Exempts Numerous Medical Devices from 510(k) Premarket Notification Requirements

The United States Food and Drug Administration (FDA) issued a Notice on July 11, 2017, exempting 1,003 Class II medical devices from premarket notification requirements under Section 510(k).  The Notice indicates that anyone with pending 510(k) submissions for devices that are now exempt “should withdraw their submissions.”

According to the Notice, the exemptions from the 510(k) requirements do not apply to other statutory or regulatory requirements.  Further, the Notice indicates there are limitations on some of the exemptions.  Table 1 in the Notice lists exempt devices that are subject to general limitations of certain sections of the Code of Federal Regulations (CFR).  Table 2 lists exempt devices subject to those general limitations and that must comply with partial exemption limitations as indicated in the table.  Table 3 lists exempt devices classified as “radioallergosorbent (RAST) immunological test systems” but which are only a subset of all devices in that classification.

The FDA claims the exemptions “will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations.”  Further, the Notice states, “regulated industry will no longer have to invest time and resources in premarket notifications, including preparation of documents and data for submission to FDA, payment of user fees associated with 510(k) submissions, and responding to questions and requests for additional information from FDA during 510(k) review.”

The Notice was published in accordance with procedures established by the 21st Century Cures Act, which was signed into law December 13, 2016.  According to the Notice, the 21st Century Cures Act requires the FDA to publish a list of each type of exempt class II device within 90 days after enactment of the Act and at least once every 5 years thereafter.  The Notice reflects the FDA’s final determination regarding a proposed list of devices for exemption issued earlier this year.  The relevant codified language for each listed device will be amended by the FDA in a “future action.”

Tom Cowan
Tom Cowan is an associate in the San Diego office of Knobbe Martens. His practice focuses on patent prosecuting and counseling in the mechanical and medical device spaces; trademark registration; licensing; handling cease and desist disputes for patents and trademarks; and analyzing patent portfolios including performing due diligence for patent portfolio acquisitions. Sample medical device technologies include auto-injector devices and systems, prostheses, tissue regeneration scaffolds, bone and tissue anchors, lateral flow assays, photoacoustic systems, raman spectroscopy techniques, intragastric devices, remote healthcare systems, thermoformable composites for immobilizing body parts, personal movement assistance devices, and more. While in law school, Mr. Cowan also received a Master of Science Degree in Biomedical Engineering. Prior to attending law school, Mr. Cowan interned at NASA and was a mechanical engineer at Northrop Grumman where he designed and tested spacecraft structures and mechanisms. Mr. Cowan was a summer associate at Knobbe Martens in 2012 and joined the firm in 2013.
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