United States: Clarifying Clinical Decision Support: FDA Overhauls Guidance To Focus On Risk

On 27 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released the draft guidance entitled "Clinical Decision Support Software" (CDS guidance), which updates the framework for FDA's oversight of CDS products, substantially revising the draft guidance that was previously released in 2017, " Clinical and Patient Decision Support Software." FDA simultaneously issued a number of final guidance documents updating the medical software regulatory framework developed to implement the 21st Century Cures Act (Cures Act), which we discuss in a companion client update.

The new draft guidance adopts a risk-based framework for evaluating CDS that resembles the approach used by FDA in the "Policy for Device Software Functions and Mobile Medical Applications" guidance. It seeks to clarify FDA's current thinking on the types of CDS software functions that: (1) are not medical devices; (2) meet the definition of a device, but will be subject to FDA's exercise of enforcement discretion (not actively regulated) due to low risk; and (3) are actively regulated. The new draft guidance presents a significant departure from the previously released version, including updates to address industry's concerns with the prior version of the guidance.

Device and nondevice CDS

Building on the statutory language enacted under the Cures Act, the guidance acknowledges that some CDS products will not meet the definition of a medical device. The Cures Act amended Section 520 of the Federal Food, Drug, and Cosmetic Act to exclude certain software functions, including some CDS, from FDA regulation. CDS products are no longer medical devices if they meet four specific criteria. Of these, the most challenging to interpret has been the criterion that the CDS must enable health care professionals (HCPs) to independently review the basis for recommendations presented by the software. The new draft CDS guidance seeks to clarify how this criterion may apply to machine learning and proprietary algorithms. It explains that companies must describe the data used to develop the algorithm and the logic or rationale used by the algorithm to render a recommendation, i.e., inputs used to generate recommendations should be identified, and should be communicated in plain language, so that the intended HCP user is able to independently evaluate the basis for the recommendation.

The draft guidance provides 12 specific examples of types of software that may be considered nondevice CDS functions because they meet all four criteria specified in the Cures Act for falling outside the definition of a medical device. These include, for example:

  • Providing HCPs with recommendations on the use of a prescription drug or medical device consistent with the FDA-required labeling.
  • Suggesting an intervention or test consistent with clinical guidelines and/or labeling, e.g., suggesting HCPs order G6PD deficiency tests before starting an antimalarial
  • Making chemotherapeutic suggestions based on patient history, test results, and patient characteristics, consistent with clinical guidelines and/or labeling.

In every instance, the critical caveats are that the basis for the recommendations must be described, including data inputs and algorithm sources, such that the HCP need not rely primarily on the software's recommendation and can make an independent, informed judgment about the appropriate clinical approach for the patient in question.

The CDS draft guidance risk categorization

If a CDS product does not meet all four of the Cures Act criteria, then it would be a device CDS and could be regulated by FDA. The most significant revision in the new draft guidance to the prior policy is the adoption of a risk-based approach to determining when device CDS would be actively regulated. This came at least partly in response to industry comments to the earlier draft guidance. Specifically, FDA intends to leverage factors developed in "'Software as a Medical Device': Possible Framework for Risk Categorization and Corresponding Considerations" (IMDRF framework) to apply a risk-based policy for defining CDS software functions as devices and determining whether CDS devices are subject to enforcement discretion.

The IMDRF framework, as explained in the draft guidance, deploys two major factors in a matrix to assign risk categorization of Software as a Medical Device (SaMD): (a) the significance of information provided by a SaMD to the health care decision, and (b) the state of the health care situation or condition (i.e., critical, serious, or non-serious). The significance of the information to the health care decision is categorized as (in descending order of risk) "treat or diagnose," "drive clinical management," or "inform clinical management." FDA explains that it only considers software that is used to "inform clinical management" as CDS, because CDS functions – per the Cures Act criteria – are intended to provide information that supports or serves as a recommendation about prevention, diagnosis, or treatment of a disease/condition, but is not necessary to decision-making for a patient's care (CDS guidance at 13 - 14). Accordingly, SaMD functions that "drive clinical management" or "treat or diagnose" are not considered CDS under the Cures Act and are not the focus of this guidance document.

Enforcement discretion and regulatory focus

Building on the risk-based framework, the new draft guidance indicates that FDA does not intend to enforce compliance for device CDS software functions under certain circumstances. Per the draft guidance, the following combinations of intended CDS audience, severity, and transparency would be subject to enforcement discretion:

  • Device CDS intended for HCP users for "non-serious situations or conditions" where the user cannot independently review the basis.
  • Device CDS intended for the patient or caregiver for "non-serious situations or conditions" and where the user can independently evaluate the basis for the recommendations.

The agency's regulatory oversight will instead focus on:

  • CDS intended for HCPs for "serious" or "critical" situation or conditions and not intended to enable independent evaluation of the basis for the recommendation.
  • CDS for patient or caregiver use unless it is both intended for a "non-serious situation or condition" and the user can independently review the basis for the recommendation.

Finally, the guidance provides 20 specific examples of non-CDS device software functions that will fall within the focus of FDA's regulatory oversight because they do not meet the four Cures Act criteria for exclusion from the device definition and are not otherwise considered to be sufficiently low-risk to be subject to enforcement discretion. These examples include software that analyzes and or manipulates data from medical images or physiological signals in order to generate a treatment plan, guide surgery, design custom implants, or aid in diagnosis of a disease or condition.

Patient decision support

The new draft guidance eliminates "patient decision software" as a separate category of clinical decision support tools. The patient decision support concept that was prominent in the previous draft guidance has not entirely disappeared. However, applying the IMDRF risk prioritization framework to this group of products, the draft guidance assigns more conservative oversight focus and enforcement discretion categories if the intended user is a patient or caregiver than if the intended user is an HCP. Moreover, consistent with the statute and the prior draft guidance, only CDS intended for use by HCPs, rather than patients, can fall outside the definition of a medical device and accordingly not be subject to FDA regulation (assuming it meets all of the Cures Act criteria).

Conclusion

FDA's substantially revised draft guidance reflects a significant shift toward a risk-based framework using IMDRF risk categorization from earlier regulatory compartmentalization of "patient" vs. "clinical" decision support software. The move suggests that FDA is listening to industry and trying to clarify pressing concerns, such as the regulation of CDS products that include machine learning or artificial intelligence algorithms. Opportunities to comment further with this newly released – essentially starting anew – draft guidance may prove highly productive toward reaching an effective industry-responsive policy that supports innovation in the CDS space.

Comments to the CDS guidance will be accepted for 90 days (until 26 December) at docket number FDA-2017-D-6569.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
Similar Articles
Relevancy Powered by MondaqAI
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions