FDA Issues Guidance on “Abbreviated” and “Special” 510(k) Pathways

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The U.S. Food and Drug Administration (FDA) has issued two new guidance documents related respectively to an “abbreviated” and a “special” approach to the typical 510(K) process for medical devices.

The FDA describes the usual 510(K) process as “a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device…that is not subject to premarket approval.”  According to the FDA, “Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval application (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) .”

Now, two recent guidance documents issued by the FDA allow for altered 510(K) approaches for certain medical devices.  The first guidance, issued September 13, 2019, is for a “Special 510(K) Program.”  The FDA describes this program as “an optional pathway for certain well-defined device modifications where a manufacturer modifies its own legally marketed device, and design control procedures produce reliable results that can form, in addition to other 510(k) content requirements, the basis for substantial equivalence (SE).”  The guidance is intended to clarify “the types of technological changes appropriate for review as Special 510(k)s.”  The new guidance also supersedes prior FDA guidance from 1998 regarding Special 510(k) policy in “The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.”

This MDDI article purports to offer a “handy checklist” to determine “if changes made to your medical device can be reviewed under the [Special 510(K)] program.”  Some of the questions listed on the article’s checklist include the following:

  • Is it a change to the manufacturer’s own device?
  • Are performance data needed to evaluate the change?
  • Is there a well-established method to evaluate the change?
  • Can the data be reviewed in a summary or risk analysis format?

The second FDA guidance, also issued September 13, 2019, is for the “Abbreviated 510(K) Program.”  The FDA describes the program as “an optional approach that may be used to demonstrate substantial equivalence in premarket notifications (510(k)s)” and that “uses guidance documents, special controls, and/or voluntary consensus standards to facilitate FDA’s premarket review of 510(k) submissions.”   The guidance is “intended to facilitate 510(k) submission preparation by manufacturers and review by FDA.”

A copy of the guidance for the Special 510(K) Program can be found here, and a copy of the guidance for the Abbreviated 510(K) Program can be found here.   The FDA currently states that comments on either guidance may be submitted at any time.  Public comments on the guidance for the Special 510(K) Program may be submitted here and for the Abbreviated 510(K) Program here.

Tom Cowan
Tom is a Partner in the San Diego office and serves clients worldwide in aerospace, mechanical, and medical technologies. He counsels clients on overall IP strategy, performs IP audits, prosecutes patents and trademarks, conducts pre-litigation enforcement of IP rights, negotiates licenses, and conducts offensive and defensive diligence such as patentability and infringement studies. As a former aerospace engineer with experience at NASA and Northrop Grumman, and holding a master’s degree in biomedical engineering, Tom’s legal services are supplemented with his advanced technical abilities in a wide range of inventive domains. Tom has particular experience with assisting startups from the conceptual design phase through acquisition. One recent example is Millipede, Inc., developer of a heart valve annuloplasty device. Tom prosecuted their patent portfolio and provided defensive patent diligence, resulting in investments and an acquisition by Boston Scientific totaling $540,000,000. Other example particular technologies in Tom’s patent experience include cardiac devices, intracranial sensors, prosthetics, aircraft and rockets, robotics, unmanned aerial vehicles (drones), semiconductors, imaging and biosensors, high altitude balloons, control systems, thermal management systems, software, and more. Additional highlights include: Keynote Speaker, “Patent Basics for the Aerospace Industry,” at the 2019 Space Foundation Space Commerce Workshop Former Mechanical engineer at Northrop Grumman, where he designed and tested complex structures and mechanisms for various spacecraft programs Interned at NASA Armstrong Space Center, Aerodynamics Branch, where he analyzed data for the Quiet Supersonic Platform Inventor of the “Inflate-A-Brake,” a system for de-orbiting small satellites to reduce space debris Publications Coordinator for the firm’s medical device practice group, which leads the nation in medical device patent prosecution having obtained over 4,800 medical device patents since 1976 and 2,700 medical device patents since 2010 Member of the firm’s pro bono committee and coordinates with the U.S. Patent & Trademark Office’s regional patent pro bono program to assist indigent individuals and non-profit organizations Co-Chair of the Licensing Executives Society (LES) for the San Diego Chapter Holds a minor in Chinese and studied Chinese language and history at Shaanxi Normal University in Xian, China
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