United States: FDA Publishes Long-Awaited Draft Guidance On 510(k) Requirements For Modified Devices


On August 5, 2016, the US Food and Drug Administration (FDA) posted two long-awaited draft guidance documents intended to help industry and FDA staff determine whether a new premarket notification (510(k)) is required upon the modification of a legally marketed medical device. 

In Depth

Under FDA regulations, a device manufacturer must submit a new 510(k) when a modification "could significantly affect the safety or effectiveness of the device" or represents a "major change or modification" in the intended use of the device. 21 C.F.R. § 807.81(a)(3). Because the quoted terms are not defined in the regulations, FDA and manufacturers often reach differing conclusions with respect the same post-modification device. The draft guidance documents—entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (hereinafter, the General Guidance) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (hereinafter, the Software Guidance), respectively—outline a series of detailed considerations that are intended to facilitate consistent interpretation of the applicable standards by FDA staff and manufacturers. As the titles of the documents suggest, the General Guidance applies generally to manufacturers of medical devices subject to the 510(k) requirement (including stand-alone software that is a medical device), while the Software Guidance applies to changes to software changes to devices.

The General Guidance document is lengthy (76 pages) and articulates policies that are largely consistent with FDA's 1997 guidance, which remains FDA's most recent official articulation of its policy on this issue. The General Guidance sets forth several "guiding principles" for determining whether a new 510(k) is required:

  • Modifications made with the intent to significantly improve safety or effectiveness of a device. If a modification is made with the intent to significantly improve the safety or effectiveness of the device, a new 510(k) is likely required.
  • "Could significantly affect" evaluation and the role of testing. The manufacturer should conduct a risk-based assessment of whether a change could significantly affect the device's safety or effectiveness, either positively or negatively. The risk-based assessment should identify and analyze all new risks and changes in known risks resulting from the modification.
  • Unintended consequences of changes. Manufacturers should consider whether there are any unintended consequences or effects associated with the modification.
  • Use of risk management. Hazards and hazardous situations, risk estimation, risk acceptability, risk control, risk/benefit analysis and overall risk evaluation are all concepts that can be applied during the design and development of a device.
  • Evaluating simultaneous changes. Because many simultaneous changes may be considered at once, each change should be assessed separately, as well as in aggregate.
  • Appropriate comparative device and cumulative effect of changes. A manufacturer's risk-based assessment should compare the modified device to the version of the device that was found to be substantially equivalent in their most recently cleared 510(k).
  • Documentation requirement. The FDA's Quality System Regulation (QSR) requires the documentation of device changes.
  • 510(k) submissions for modified devices. When a new 510(k) is submitted for a device with multiple modifications, that 510(k) should describe all changes that trigger the requirement for a new 510(k). That 510(k) should also describe other modification(s) since the last cleared 510(k) that would have been documented as part of an original 510(k) for that device.
  • Substantial equivalence determinations. Even if a manufacturer follows this guidance and submits a new 510(k), a substantially equivalent determination is not assured.

The General Guidance also offers detailed flow charts and narrative text to guide manufacturers through FDA's recommended logic scheme, as well as dozens of examples illustrating the application of the proposed framework. Given the level and depth of information provided, the FDA divides the General Guidance framework into shorter schemes that describe how manufacturers should assess

  • Labeling changes
  • Technology, engineering and performance changes
  • Materials changes
  • Technology, engineering, performance and materials changes for in vitro diagnostic devices (IVDs)
  • Considerations for risk assessments of modified devices

The Software Guidance includes much of the same information as the General Guidance (e.g., the same "guiding principles"). The Software Guidance also offers the following overarching guidance specific to the review of modifications to software:

  • Software changes made solely to strengthen cybersecurity, protect information and reduce disruption in service without impacting the performance of the device likely do not require a new 510(k).
  • Software changes made solely to restore the device to its most recently cleared specifications likely do not require a new 510(k).
  • Subject to certain outlined criteria, software changes that introduce a new or alter an existing cause or type of hazardous situation that is not mitigated in the most recently cleared device likely require a new 510(k). A hazardous situation exists when there is a potential for exposure to physical injury or damage to health. The cause of a hazardous situation should be identified and defined by the manufacturer in the device's risk management file.
  • Software changes that introduce new risk control measures or implement changes to prevent significant harm likely require a new 510(k). Note, however, that a new 510(k) is likely not required as a result of a manufacturer implementing additional risk control measures, provided such measures have not been added in response to a new, modified or previously known hazardous situation or causes thereof.
  • Software changes that may significantly affect clinical functionality or performance specifications that are directly associated with a device's intended use likely require a new 510(k).

The Software Guidance includes dozens of examples illustrating FDA's application of these principles.

Comments on the draft guidance documents should be submitted to the FDA by November 7, 2016.


The agency's position with respect to the 510(k) requirement for modified devices has long been the subject of angst within industry, particularly since the agency's 2011 publication of a (subsequently withdrawn) guidance document that, in industry's view, would have substantially increased the number of device modifications triggering the requirement for a new 510(k). In the General and Software Guidance documents, the FDA takes the feedback it has received from industry into account in articulating its overarching considerations. That being said, medical device manufacturers of all types—as well as manufacturers of certain products that may soon be subject to regulation as medical devices (e.g., developers of laboratory-developed tests (LDTs))—should carefully review the principles articulated in the documents and consider offering comments to the agency, particularly insofar as the agency takes a position that appears to unreasonably subject a group of modifications to additional regulatory scrutiny.

FDA Publishes Long-Awaited Draft Guidance on 510(k) Requirements for Modified Devices

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
McDermott Will & Emery
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
McDermott Will & Emery
Related Articles
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
Registration (you must 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