December 12, 2017
Authored and Edited by Ryan H. Ellis; Susan Y. Tull
In December 2017, FDA released draft Guidance on the FDA’s current interpretation of Section 3060(a) of the 21st Century Cures Act, which was enacted on December 13, 2016. The Cures Act amended Section 520 of the FDCA by adding Section 502(o). Section 520(o) amended the definition of “device” to exclude certain software functions. In short, Section 520(o) described software functions that were no longer included as regulated medical devices.
In the Guidance, FDA indicated that the Cures Act is function-related and platform agnostic and addressed four major software functions not included in the definition of device from section 520(o)(1)(A)-520(o)(1)(D). FDA provided an explanation of its current thinking for each specific software function:
Software Function Intended for Administrative Support of a Health Care Facility: FDA explained that Section 520(o)(1)(A) of the FDCA indicated that a software function intended “for administrative support of a health care facility,” is not a device, a position consistent with historic FDA practice. FDA went on to explain that it would remove Section 3.2.2 of the Guidance for Off-the-Shelf Software Use in Medical Devices because this type of software was no longer included under Section 201(h), as amended by the Cures Act.
Software Function Intended for Maintaining or Encouraging a Healthy Lifestyle: FDA indicated that Section 520(o)(1)(B) of the FDCA stated that a software function intended “for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition,” is not considered a device. FDA clarified that a “healthy lifestyle” means a product that encourages a “general state of health or healthy activity,” as defined in previous FDA guidance “General Wellness: Policy for Low Risk Devices.” General wellness products include: (1) products that “are intended for only general wellness use” and (2) products that “present a low risk to the safety of users and other persons.” FDA further defined general wellness intended uses as excluding a software function that is related to the “diagnosis, cure, mitigation, prevention, or treatment of a disease or condition,” unless that software function “presents a low risk to the safety of users and other persons.” In the latter case, FDA stated that they would not enforce the applicable requirements. FDA went on to give examples of software functions that were not devices, such as “[a] mobile application that plays music to ‘soothe and relax’ an individual and to ‘manage stress,’” and explained that the existing guidelines would be changed to include the examples.
Software Function Intended to Serve as Electronic Patient Records: FDA indicated that Section 520(o)(1)(C) of the FDCA stated “software functions intended to transfer, store, convert formats, or display electronic patient records that are the equivalent of a paper medical chart are not devices so long as all the criteria of section 520(o)(1)(C)(i)-(iii) are met,” with those criteria spelled out in the Guidance. But FDA stated that it would not enforce the FDA requirements for software functions that do not meet the criteria of Section 520(o)(1)(C)(ii), so long as the criteria for Sections 520(o)(1)(C)(i) and (iii) are met. However, FDA stated that it will address, in a later guidance document, software functions that do not meet the criteria that are included in a system with software functions that do not meet the definition of device. The Guidance explained how FDA would update prior guidance documents to reflect its new policies.
Software Function Intended for Transferring, Storing, Converting Formats, Displaying Data and Results: FDA indicated that Section 520(o)(1)(D) of the FDCA stated that a device “does not include a software function that is intended ‘for transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results unless such function is intended to interpret or analyze clinical laboratory test or other device data, results, and findings.’” Specifically, software functions that meet the definitions of medical device data systems, medical image storage devices, or medical image communications devices are not regulated devices. The Guidance indicated that “software functions that analyze or interpret medical device data in addition to transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results remain subject to FDA’s regulatory oversight.” The Guidance explained further that “software functions intended to generate alarms or alerts or prioritize multi-patient displays, because these functions involve analysis or interpretation of laboratory test or other device data and results” are not included in Section 520(o)(1)(D), but clarified FDA does not intend to regulate software functions unless they “alert a caregiver to take an immediate clinical action.” As with other changes, FDA intends to update all relevant guidelines to reflect its clarifications.
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
Workshop
Life Sciences Workshop: Updates and Key Trends in Pharmaceutical and Biotechnology IP Law
May 2, 2024
Cambridge
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.