United States: FDA Announces Digital Health Innovation Action Plan To Implement 21st Century Cures Act

Last Updated: August 21 2017
Article by Michele Buenafe and M. Elizabeth Bierman

Agency also launches voluntary pilot program as first step in developing software pre-certification program.

On July 27, the US Food and Drug Administration (FDA or Agency) published its Digital Health Innovation Action Plan, which provides details and timelines for implementation of the 21st Century Cures Act and describes other activities FDA is undertaking to develop an innovative approach for the regulation of digital health products.

As part of this plan, FDA is announcing a voluntary pilot program intended to help create a new pre-certification program for eligible digital health developers. The objective is to create a new program that would allow FDA to pre-certify developers that meet certain quality and other criteria. Pre-certified developers would then be able to market their lower-risk software devices without FDA premarket review or with a more streamlined review and more limited data requirements.

This new action plan signals FDA's continued commitment under Commissioner Scott Gottlieb to further optimize digital health regulation and fulfill its obligations under the recently enacted 21st Century Cures Act.

Issuance of Guidance to Implement 21st Century Cures Act Provisions and Clarify FDA's Oversight of Software

FDA intends to issue three new draft guidances and two final guidances between the end of 2017 and the first quarter of 2018.

The three new draft guidances are the following:

  • 21st Century Cures Implementation Guidance. By the end of 2017, the Agency plans to issue a draft guidance to interpret several of the medical software provisions in the 21st Century Cures Act and to explain their impact on FDA's preexisting policies. As we described in a prior LawFlash, the language used in the 21st Century Cures Act does not precisely "track" language used in existing FDA guidances—including the Mobile Medical Applications guidance, the General Wellness guidance, and the Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices guidance. Thus, a new guidance is needed to understand precisely what products are exempt from the statutory definition of "device" pursuant to the new law.
  • Clinical Decision Support Software. FDA plans to issue during the first quarter of 2018 the long-awaited guidance on clinical decision support software. Prior governmental announcements by the Office of the National Coordinator for Health Information Technology and FDA already created ambiguity regarding what clinical decision support (or "CDS") technologies are or will be subject to regulation, and this ambiguity has only been enhanced by language in the 21st Century Cures Act (as noted in our prior LawFlash). Accordingly, this new guidance will be of particular importance to many in the digital health industry.
  • Multifunctionality. The 21st Century Cures Act raises the issue of how FDA will review products that include both regulated and unregulated functions. Developers of wearable products that include sensors to assess both health/fitness and medical conditions increasingly will face this scenario, and the new draft guidance will provide important clarification on how FDA reviewers will evaluate these multifunctional products. FDA stated that its goal is to issue the draft guidance during the first quarter of 2018 for public comment.

Additionally, FDA has stated that it will finalize the following guidance documents, which were previously issued in draft form:

  • Deciding When to Submit a 510(k) for a Software Change to an Existing Device. This document, which issued in draft in August 2016, provides guiding principles for medical device manufacturers on the type of software modifications that may necessitate the submission and clearance of a new 510(k). FDA intends to finalize this guidance before the end of 2017.
  • Software as a Medical Device (SaMD): Clinical Evaluation. As described in our prior LawFlash, FDA proposed adoption of this International Medical Device Regulators Forum (IMDRF) guidance document in October 2016. FDA expects IMDRF to finalize this document in September 2017, after which FDA will issue a final guidance document "adopting the internationally converged principles, as appropriate." However, it remains to be seen whether FDA intends to simply adopt the IMDRF version or, as suggested by some of the public comments, issue its own guidance that incorporates IMDRF's principles but better aligns with FDA's existing regulatory scheme, device classification system, and terminology.

FDA Pre-Certification Pilot Program for Digital Health Developers

FDA also announced its intent to launch a voluntary pilot program for digital health developers as part of its effort to create an innovative regulatory framework that recognizes the unique, constantly evolving nature of digital health technology. Specifically, FDA hopes to gather information and experience from the pilot program in order to create a pre-certification program under which FDA would focus on the software developer rather than the product. As noted above, once established, the pre-certification program would allow developers that meet certain criteria established by FDA relating to quality and organizational excellence to become pre-certified by the Agency. Pre-certified developers would potentially be able to market their lower-risk devices without a premarket submission or with a submission that requires less data and information and is reviewed more quickly.

Under the pilot program, FDA is seeking to partner with nine digital health developers to gain a better understanding of how these developers operate. FDA would use this information to create the pre-certification program. Although participants would not become pre-certified under the pilot program, they would have a unique opportunity to influence FDA's establishment of a potentially groundbreaking regulatory framework for digital health.

FDA began accepting requests for participation in the pilot program on August 1, and the program is scheduled to begin on September 1.

This article is provided as a general informational service and it should not be construed as imparting legal advice on any specific matter.

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.

In association with
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). 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 & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd 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 or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.