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

| Printer friendly version

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 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.
Click here to read full bio
View all posts published by Tom Cowan »

Leave a Reply

By using this blog, you agree and understand that no information is being provided in the context of any attorney-client relationship. You further agree and understand that nothing herein is intended to be legal advice. This blog is solely informational in nature, and is not intended as, and should not be used as, a substitute for competent legal advice from a retained and licensed attorney in your state. Knobbe Martens LLP makes no representations or warranties as to the accuracy, completeness, timeliness or availability of the information in this blog. Knobbe Martens LLP will not be liable for any injury or damages relating to your use of, or access to, any such information. Knobbe Martens LLP undertakes no obligation to correct or update information on this blog, which may be incorrect or become incorrect or out of date over time. Knobbe Martens LLP reserves the right to alter or delete content or information on the blog at any time. This blog contains links and references to other websites and publications that you may find of interest. Knobbe Martens LLP does not control, promote, endorse or otherwise have any affiliation with any other websites or publications unless those websites or publications expressly state such an affiliation. Knobbe Martens LLP further has no responsibility for, and makes no representations regarding, the content, accuracy or any other aspect of the information in such websites or publications.