United States: FDA Seeks Comment On Draft Guidance For Manufacture Of Interoperable Medical Devices

Keywords: FDA, Food and Drug Administration, interoperable medical devices,

This article was originally published by Law360 on February 4, 2016.

On January 26, 2016, the US Food and Drug Administration (FDA) issued draft guidance entitled Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices. FDA issues such documents to provide the agency's "current thinking" on a matter of concern to regulators and stakeholders. This particular guidance provides FDA's views on issues that device makers should consider when designing interoperable medical devices. In addition, FDA's draft guidance discusses how device makers should prepare a pre-market submission, which is a form of application for permission to market a medical device. Many companies are likely to take an interest in this proceeding given its potential to affect an array of sectors in addition to the health care sector, including communications and Internet technology companies, wireless device manufacturers and communications infrastructure providers. The FDA seeks comment on the draft guidance on or before April 28, 2016.


In the context of health information technology (HIT), the term "interoperable" refers to the ability of different information technology systems and software applications to communicate, exchange and use data seamlessly. The new interoperability guidance discussed below is another step in the FDA's efforts to implement the recent mandate set forth in the Food and Drug Administration Safety Innovation Act. In 2012, Congress tasked three agencies—FDA, the Federal Communications Commission and the Office of the National Coordinator for Health Information Technology (ONC) (an agency within the Department of Health and Human Services)—with producing recommendations for a new HIT regulatory framework that would balance the goals of promoting innovation, protecting patient safety and avoiding regulatory duplication. Interoperability would be a critical component of such a new regulatory scheme.

FDA states that, "[i]nteroperability in healthcare has the potential to encourage innovation and facilitate new models of health care delivery by promoting the availability and sharing of information across systems even when products from different manufacturers are used. However, one of the more controversial aspects of this multi-agency effort has been the goal of ensuring interoperability among medical devices. In theory, interoperable medical devices would improve the efficiency of health care delivery by, for example, enabling providers in different specialties located at different institutions to share patient information quickly, thus facilitating faster treatment based on more complete information. At the same time, given the healthcare context, medical device interoperability has raised concerns about safety and privacy Concerns about privacy have become particularly acute given heightened sensitivity to cybersecurity threats.

The new interoperability guidance is divided into two principal sections; the first addresses design and the second addresses pre-market submissions.

Design Considerations for Interoperable Medical Devices

The FDA guidance provides detailed information and recommendations for device design and stresses the critical importance of ensuring safety. To that end, FDA states that device makers should perform a risk analysis and conduct appropriate testing that considers risks associated with the proposed technology, such as failures or malfunctions resulting from improper connection of devices or invalid commands. FDA suggests that clear labeling regarding the functional, performance and interface requirements of the proposed device, as well as its limitations, would promote safe use. More specifically, FDA provides detailed recommendations on six prime considerations for device design including (1) the purpose of the interface, (2) the anticipated users, (3) risk analysis and management, (4) verification and validation testing, (5) thoroughness and specificity of labeling and (6) the use of consensus standards. With regard to consensus standards, FDA acknowledges the benefits of designing medical devices that incorporate published consensus standards in general and particularly in the context of interoperable medical devices. Further, FDA explains that these benefits are maximized when not only medical device makers but all stakeholders, including health care organizations and providers, medical system designers and integrators and IT professionals, take part in the standards-setting process. Consider: In this regard, FDA cites the CDRH Recognized Consensus Standards Database, a data collection maintained by its Center for Devices and Radiological Health, as a source for identifying potential interoperability standards.

Recommendations for Pre-Market Submissions

As a threshold matter, FDA recognizes that "not all interoperable medical devices may require pre-market submission." For those that do, however, FDA suggests that sponsors should "consider any other appropriate guidances or special controls applicable to the device." FDA next provides detailed recommendations on four main issues germane to the preparation of pre-market submissions, which overlap considerably with the interoperability design considerations. FDA requests that pre-market submissions include (1) the device description, (2) risk analysis, (3) verification and validation and (4) labeling. With regard to labeling, FDA provides lengthy, proscriptive requirements, which include discussing the purpose for the medical device and the data, describing interface specifications and providing a testing summary, citing the standards followed, explaining the limitations of the device, recommending steps for ease of use and writing proposed instructions for IT personnel.


FDA's guidance concludes by stating that "the use and development of standards that support interoperability of medical devices is vital to creating interoperable systems that are reliable and safe," which illustrates the agency's view that developing and implementing consensus-based standards is essential to achieving a modern, efficient HIT regulatory framework. At the same time, FDA acknowledges the competing priorities of developing new and innovative interoperable medical devices and protecting patient safety and privacy. As such, FDA should conduct a fact-based technical analysis to assess the costs and potential burdens for medical device manufacturers and others in the HIT marketplace of developing interoperable medical devices that meet applicable standards for safeguarding patient information. FDA has authority to regulate medical devices for safety and efficacy, and to that end to mandate specific requirements for such matters as labeling, testing, and validation. But FDA cannot compel interoperability itself, any specific design or function related to interoperability, or require specific standards for interoperability. The draft guidance did not mention activities of or coordination with other agencies that may be involved in that process such as the FCC and ONC. This area may be fertile ground for inquiry by stakeholders during the comment process.

Originally published February 5, 2016

Learn more about our Life Sciences practices.

Visit us at mayerbrown.com

Mayer Brown is a global legal services provider comprising legal practices that are separate entities (the "Mayer Brown Practices"). The Mayer Brown Practices are: Mayer Brown LLP and Mayer Brown Europe – Brussels LLP, both limited liability partnerships established in Illinois USA; Mayer Brown International LLP, a limited liability partnership incorporated in England and Wales (authorized and regulated by the Solicitors Regulation Authority and registered in England and Wales number OC 303359); Mayer Brown, a SELAS established in France; Mayer Brown JSM, a Hong Kong partnership and its associated entities in Asia; and Tauil & Chequer Advogados, a Brazilian law partnership with which Mayer Brown is associated. "Mayer Brown" and the Mayer Brown logo are the trademarks of the Mayer Brown Practices in their respective jurisdictions.

© Copyright 2016. The Mayer Brown Practices. All rights reserved.

This Mayer Brown article provides information and comments on legal issues and developments of interest. The foregoing is not a comprehensive treatment of the subject matter covered and is not intended to provide legal advice. Readers should seek specific legal advice before taking any action with respect to the matters discussed herein.

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.