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FDA Published List of Class II Devices to be Exempt From 510(K) Process

As we previously reported, Congress passed, and then-President Obama signed, the 21st Century Cures Act last November to implement a number of FDA reforms. Among the reforms affecting medical devices was a requirement for the FDA to publish a notice in the Federal Register – within 120 days for Class I devices and within 90 days for Class II devices – that identifies devices that no longer require clearance under Section 510(k). On schedule, the FDA has published the list of Class II devices here.

For Class II devices, the Act says the FDA must also provide a 60-day notice and comment period and finalize the list within 210 days. Electronic or written comments on the notice are due on or before May 15, 2017.

The Class II list includes approximately 35 pages of devices from 21 CFR Part 862, which governs clinical chemistry and clinical toxicology devices. Although the list includes many devices in this category, part of the reason for its length is that the exemption for several of the devices is limited to test systems intended for employment and insurance testing and does not include test systems intended for federal drug testing programs. Other exemptions are subject to limitations also. For example, the list includes an exemption for an endoscopic magnetic retriever, but limits the exemption to such devices that are for single use.

The list also includes a 15-page table of Radioallergosorbent (RAST) immunological tests, which fall under 21 CFR 866.5750, for specific allergens.

Finally, the list includes at least some devices from each of the other classifications, Parts 864-892. Medical device firms will want to review the list to determine if any of their current or proposed products are now exempt.

The FDA is to update the Class I and Class II lists every five years.

The notice cautions that an exemption from the 510(k) process “does not mean that the device is exempt from any other statutory or regulatory requirements, unless such exemption is explicitly provided by order or regulation.” The FDA states that its initial determination that premarket notification is unnecessary to provide a reasonable assurance of safety and effectiveness for devices listed in the notice is based, in part, on the assurance of safety and effectiveness that other regulatory controls, such as current good manufacturing practice requirements, provide.



About this Author

Lynn C. Tyler, M.S, Barnes Thornburg Law Firm, Patent Attorney

Lynn C. Tyler is a partner and registered patent lawyer in the firm’s Intellectual Property Department. Mr. Tyler helps innovative companies secure and preserve their market position and competitive advantage by navigating their way through the FDA to the marketplace and enforcing their intellectual property rights, which often must be protected against imitators who seek to reap where they have not sown. He litigates intellectual property matters and represents clients at virtually all stages of the process, including pre-litigation counseling, alternative dispute resolution, formal and...

Elizabeth Davis, Barnes Thornburg, Environmental lawyer, product liability law,

Elizabeth B. Davis is a partner in the Atlanta office of Barnes & Thornburg LLP and is a member of the firm’s Environmental Department. Ms. Davis focuses her practice on environmental and product liability matters.

Ms. Davis provides a broad spectrum of support to her business clients. As a former assistant regional counsel with the U.S. Environmental Protection Agency, Region 4, Ms. Davis has experience with regulatory compliance, permitting, enforcement defense and litigation. She counsels clients and litigates in virtually all aspects of federal and state laws related to hazardous waste, underground storage tanks, water, air, pesticides, toxic substances and occupational safety and health.


Alicia M. Raines is an associate in the Indianapolis office of Barnes & Thornburg LLP where she is a member of the firm’s Litigation Department. Ms. Raines is also a member of the firm’s Commercial Litigation Practice Group. Prior to joining Barnes & Thornburg, Ms. Raines was a summer associate in the firm’s Indianapolis office. Additionally, she has served as an intern for the U.S. Army Corps of Engineers, and the William & Mary Office of Diversity and Equal Opportunity.