United States: The FDA And Cybersecurity: How The Agency Is Addressing Cybersecurity Risks To Medical Devices

The Situation: As medical devices become more connected to each other and to the internet, an increasing number of patients are exposed to cybersecurity risks.

The Result: Over the last five years, the Food and Drug Administration ("FDA") has issued new guidance and policy to address cybersecurity issues and has been advised by the Office of Inspector General ("OIG") to take additional steps. Manufacturers should be aware of, and prepare for, the actions FDA undertakes on its own initiative and as a result of the OIG recommendations.

Looking Ahead: Although FDA recognizes that cybersecurity of medical devices is a shared responsibility across the ecosystem, manufacturers of networked medical products have the primary responsibility for managing the cybersecurity risks presented by their products and potentially should be prepared to provide significant cybersecurity information to FDA.

Because of recent and highly publicized data breaches across a multitude of industries, cybersecurity threats have become synonymous with the digital age, and both private and government organizations have invested significant resources into combating the risks presented by digital threats. Although FDA is, to date, unaware of medical devices being hacked or manipulated by unauthorized users while in use by a patient, the threat of such an event is not just theoretical and has received increasing attention from the Agency. Indeed, a number of medical device companies have taken action to address postmarket vulnerabilities that, if exploited, could have allowed an unauthorized user to access a patient's device using commercially available equipment. For example, the FDA has previously issued a safety communication related to a software update to address potential cybersecurity vulnerabilities associated with an implantable device.

FDA's Center for Devices and Radiological Health ("CDRH") is responsible for the oversight of medical devices, including those that are digitally connected to each other or to larger networks, such as the internet. The expanded connectivity of medical devices has led to improvements in patient care and greater efficiencies in the healthcare system (e.g., remote control of devices through mobile apps, as well as faster processing/analyzing of patient data), but also presents new and different types of risks that must be addressed to ensure such products are safe for patient use.

Manufacturers of networked medical devices are required to address their device's cybersecurity risks as part of an FDA submission for marketing authorization. The Quality System Regulations at 21 CFR § 820.30(g) state that, as part of a device's design controls, manufacturers must "establish and maintain procedures for validating the device's design," which includes "software validation and risk analysis, where appropriate." Notably, these regulations do not specifically address cybersecurity; they were issued before cybersecurity became a central consideration of medical device design. Understanding that industry may be confused about what this regulation requires and, more broadly, FDA's role in assessing cybersecurity measures, the Agency has issued guidance and other policy documents aimed at clarifying its expectations for manufacturers of networked devices.

In 2013, FDA established the Cybersecurity Working Group within CDRH. The group is tasked with ensuring that FDA's thinking on cybersecurity issues keeps pace with the rapidly evolving threat landscape and technological developments. In 2014 and 2016, FDA issued its first two guidance documents addressing cybersecurity in the premarket and postmarket contexts, respectively. However, the 2014 guidance may end up being relatively short-lived: In October 2018, FDA issued a new draft guidance that, when finalized, will replace the 2014 guidance. The 2018 draft would significantly expand what FDA recommends manufacturers submit in terms of cybersecurity design documentation in premarket submissions. As such, the draft guidance is perceived as potentially raising the bar for marketing authorization for certain low to moderate-risk devices. The new draft postmarket guidance also suggests that informing users of relevant security information through labeling may play an important role in helping to mitigate cybersecurity risks.

The 2016 postmarket guidance outlines a risk-based framework for manufacturers to use for responding to new cybersecurity threats once a device is already in use, from patching and updates to circumstances in which reporting to FDA is warranted. The guidance leverages the National Institute for Standard and Technology's well-known cybersecurity framework—including the core functions of detection, response, and recovery—to aid manufacturers in thinking through how to address postmarket cyber risks.

Realizing that it cannot unilaterally address all medical device cybersecurity risks, FDA has also taken steps to collaborate with other organizations and has encouraged device manufacturers and healthcare providers to take greater responsibility for reacting to cybersecurity threats in the postmarket context. For instance, as detailed in the 2016 postmarket cybersecurity guidance, FDA believes it is critical for manufacturers to participate in an information sharing and analysis organization, which are intended to serve as focal points for cybersecurity information sharing. Additionally, in October 2018, FDA announced a memorandum of agreement between itself and the U.S. Department of Homeland Security to implement a new framework for greater coordination and cooperation between the two agencies for addressing cybersecurity risks in medical devices. Finally, in coordination with the MITRE Corporation, FDA helped launch a cybersecurity playbook for healthcare delivery organizations that details the types of actions such organizations should take to better respond to cybersecurity attacks.

While FDA has already taken numerous steps to address cybersecurity threats applicable to medical devices, in light of two recent reports by the U.S. Department of Health and Human Services ("HHS") Office of Inspector General ("OIG"), it appears that more is likely to come. First, in September 2018, the HHS OIG published a report concluding that FDA should "take additional steps to more fully integrate cybersecurity into its premarket review process." Specifically, OIG recommended that FDA: (i) promote the use of presubmission meetings to address cybersecurity-related questions; (ii) include cybersecurity documentation as a criterion in FDA's Refuse-To-Accept checklist; and (iii) include cybersecurity as an element in the "Smart" template to help prompt cybersecurity questions from FDA reviewers. FDA concurred with all three recommendations and has started to implement them.

In October 2018, the HHS OIG issued a second cybersecurity report, this time focusing on the Agency's policies and procedures in the postmarket context. Among other things, the report found that "FDA's policies and procedures were insufficient for handling postmarket medical device cybersecurity threats" and that "FDA had not adequately tested its ability to respond to emergencies resulting from cybersecurity events in medical devices." Based on these findings, OIG recommended that FDA: (i) continually assess the cybersecurity risks to medical devices and update its plans and strategies; (ii) establish written procedures and practices for securely sharing sensitive information about cybersecurity events with key stakeholders; (iii) enter into a formal agreement with federal agency partners; and (iv) establish and maintain procedures for handling recalls of medical devices vulnerable to cybersecurity threats. While FDA disagreed with some of the findings, the Agency again concurred with the recommendations, noting it had implemented many of them during the course of the audit.

For manufacturers of networked medical devices, the takeaway is that cybersecurity is, and will become, an increasingly emphasized aspect of FDA's regulatory oversight. It is apparent from FDA's new draft guidance and the recommendations of OIG that, moving forward, more cybersecurity information will be required than ever before. However, it is also important for device manufacturers to realize that the onus for developing and implementing adequate cybersecurity measures rests primarily with them. As detailed in FDA's Cybersecurity Fact Sheet, FDA does not conduct premarket testing for medical products, and it is the responsibility of the manufacturer to assess its own products and implement adequate risk mitigation measures. Additionally, manufacturers are responsible for the validation of all software design changes, including software changes to address cybersecurity vulnerabilities. FDA recognizes that cybersecurity is a shared responsibility across the entire health care ecosystem; ultimately, it is going to expect that manufacturers take adequate steps to assess their products for cybersecurity risks and are able to provide assurances that the identified risks have been appropriately managed and mitigated.

Three Key Takeaways

  1. As an ever-greater number of medical devices are connected to the internet, cybersecurity will become an increasingly emphasized aspect of FDA's oversight.
  2. FDA has already issued guidance documents that provide cybersecurity recommendations for medical device manufacturers in both the premarket and postmarket contexts.
  3. In light of recent OIG reports recommending that FDA take an even greater role in addressing and responding to cybersecurity threats, medical device manufacturers should be prepared to provide FDA with documentation demonstrating that cybersecurity risks have been appropriately managed and mitigated.

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.

Similar Articles
Relevancy Powered by MondaqAI
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Related Articles
Related Video
Up-coming Events Search
Font Size:
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.


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.


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