October 16, 2017
Authored and Edited by Justin A. Hendrix; Kathleen A. Daley
More than twenty years ago FDA issued final Guidance on whether to submit a new 510(k) for a change to an existing medical device. In October 2017, FDA issued new final Guidance that provides its current thinking and recommendations. Notably, at the same time, FDA issued additional final Guidance on software changes, titled Deciding When to Submit a 510(k) for a Software Change to an Existing Device.
With the ubiquity of electronics and software in today’s devices, the Guidance on software changes provides much needed direction for interpreting 21 CFR 807.81(a)(3), which requires a new 510(k) in the following instances:
3) The device is one that the person currently has in commercial distribution or is reintroducing into commercial distribution, but that is about to be significantly changed or modified in design, components, method of manufacture, or intended use. The following constitute significant changes or modifications that require a premarket notification:
(i) A change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process.
(ii) A major change or modification in the intended use of the device.
As noted in the Guidance, FDA and device manufacturers sometimes reach different interpretations of phrases in the regulation, such as a change that “could significantly affect the safety or effectiveness of the device,” or a “major change” in the intended use of the device.
The added complexity of interpreting the regulations as they apply to software changes comes from the many types of software changes that can be made, ranging from the simple correction of bugs to the wholesale change of an operating system. To address this complexity, the Guidance provides a logic flow chart, answers to common questions, and considerations regarding common software changes. Finally, to assist with understanding the flow chart, the Guidance provides specific examples of common changes along with FDA’s recommended outcome, either to submit the change in a new 510(k), or to simply document and keep a record of it. Although the Guidance cannot address every potential scenario, it provides the necessary framework for making an educated decision on when device manufacturers should submit a new 510(k) based on software changes.
Copyright © 2017 Finnegan, Henderson, Farabow, Garrett & Dunner, LLP.
DISCLAIMER: Although we wish to hear from you, information exchanged in this blog cannot and does not create an attorney-client relationship. Please do not post any information that you consider to be personal or confidential. If you wish for Finnegan, Henderson, Farabow, Garrett & Dunner, LLP to consider representing you, in order to establish an attorney-client relationship you must first enter a written representation agreement with Finnegan. Contact us for additional information. One of our lawyers will be happy to discuss the possibility of representation with you. Additional disclaimer information.
Lecture
Patent Protection for Software-Related Inventions in Europe and the USA Training Course
June 5, 2024
Hybrid
Webinar
May 9, 2024
Webinar
At the PTAB Blog
USPTO Releases Notice of Proposed Rule Making Codifying Several Precedential Case Factors
April 25, 2024
Due to international data regulations, we’ve updated our privacy policy. Click here to read our privacy policy in full.
We use cookies on this website to provide you with the best user experience. By accepting cookies, you agree to our use of cookies. Please note that if you opt not to accept or if you disable cookies, the “Your Finnegan” feature on this website will be disabled as well. For more information on how we use cookies, please see our Privacy Policy.
Finnegan is thrilled to announce the launch of our new blog, Ad Law Buzz, devoted solely to breaking news, developments, trends, and analysis in advertising law.