United States: FDA Releases Four Final Guidances On The 510(k) Program; Special 510(k) Guidance Confirms New Approach To Eligibility And Broader Potential For IVDs

On 13 September 2019 the U.S. Food and Drug Administration (FDA or the agency) published four final guidance documents on the 510(k) program:

FDA's March 1998 guidance entitled "The New 510(k) Paradigm – Alternate Approaches to Demonstrating Substantial Equivalence" (New 510(k) Paradigm guidance) is now obsolete, entirely replaced by the final guidances on Special 510(k)s and Abbreviated 510(k)s.

The most significant changes appear to be to "The Special 510(k) Program," which replaces the 28 September 2018 draft guidance of the same name. Clarifying language in the Special 510(k) final guidance underscores the agency's shift in focus for what types of submissions are eligible for the program. Criteria for acceptance for review of changes to previously cleared devices through a Special 510(k) notice will focus on whether methods to evaluate the changes are well established and whether results can be sufficiently reviewed in a summary or risk analysis format. The final guidance also indicates that in the case of in vitro diagnostics (IVDs), the need for clinical data to evaluate changes will not necessarily be a bar to acceptance to the program.

The remainder of the guidances appear to have been released primarily to make conforming changes and do not represent major shifts in policy.

The Special 510(k) guidance

The Special 510(k) guidance is largely consistent with the draft Special 510(k) guidance, discussed in detail here. The final guidance retains the draft guidance's expansion of the Special 510(k) program to allow review of certain changes to the indications for use of the device. Specifically, the final guidance clarifies that FDA's approach to Special 510(k) notices no longer emphasizes "changes that affect indications for use or alter fundamental scientific technology." Rather, in determining whether changes to an existing device can be reviewed through the Special 510(k) notice pathway versus a Traditional 510(k) notice, the agency will now focus on "whether the method(s) to evaluate the change(s) are well-established, and whether the results can be sufficiently reviewed in a summary or risk analysis format."

This approach is further established in a flowchart that instructs the reviewer to consider these two factors which, if affirmative, lead to the decision that the change is appropriate for review in a Special 510(k) submission. These are the more 'practical considerations' that FDA had always considered in assessing eligibility for the program, given its shorter initial 30-day review time, but they had not officially supplanted the prior considerations until now.

For IVDs, the final guidance carves out an exception to the practice of disqualifying for Special 510(k) consideration devices requiring clinical trial data for evaluating modifications, stating "...[t]he use of clinical specimens to conduct IVD verification and validation does not necessarily mean that a well-established method does not exist to evaluate the change." Moreover, compared to the draft, the final guidance includes five new examples of modifications involving IVDs which would be eligible for the program (and no examples which would be ineligible), suggesting expanded scope for using the Special 510(k) program for IVD changes, even those supported by clinical data.

The agency has also made clear that for certain devices – like point-of-care products that manufacture a biological product and certain reusable devices requiring reprocessing – modifications through a Special 510(k) generally would not be appropriate, due to a lack of wellestablished methods to evaluate such changes, or because the validation data would not be reviewable in summary or risk analysis format. It also clarifies that modifications that involve more than three disciplines (e.g., biocompatibility or electrical safety) generally would be ineligible (whereas the draft was not specific as to the number).

Additional guidances issued

Concurrent with the Special 510(k) final guidance, FDA released three additional guidances related to 510(k) submissions:

  • "The Abbreviated 510(k) Program" guidance excerpts and updates language from the superseded the New 510(k) Paradigm guidance (1998), without major changes in policy. It appears to have been issued mainly to separate the Special 510(k) and Abbreviated 510(k) guidances into two separate documents, and retire the New 510(k) Paradigm guidance. Notably, it makes no mention of the "Safety and Performance Based Pathway" final guidance FDA released in February 2019, which the agency described as providing, "FDA's current thinking on expanding the concept of the Abbreviated 510(k) Pathway." This omission makes clear that these are two separate programs. For more on these modernizing trends, see our analysis of the "Safety and Performance Based Pathway" final guidance.
  • Refuse to Accept (RTA) checklist: The "Refuse to Accept Policy for 510(k)s" guidance replaces the prior RTA policy guidance from February 2019 and updates the acceptance checklists for Traditional, Abbreviated, and Special 510(k) notices. In addition to the revised acceptance criteria for the Special 510(k) program discussed above, there are a few minor changes to the checklists for Traditional and Abbreviated 510(k)s. For example, there is a new section covering cybersecurity features, and there is greater specificity for test protocols and standards appropriate for assessing biocompatibility. FDA indicated it would not implement the updated checklist for 60 days following its release in order to allow industry and the agency time to operationalize the associated updates to the 510(k) RTA guidance. During this grace period (until 13 November 2019), FDA will utilize the prior final RTA guidance to assess whether a 510(k) submission should be accepted for substantive review for Special 510(k) submissions as well as for all other submission types.
  • "Format for Traditional and Abbreviated 510(k)s" replaces the guidance issued on 17 November 2005, updating internal cross-references and reflecting the agency's current preferences for 510(k) formatting.


With a focus on methods and risk analysis, these documents update FDA's approach to the 510(k) paradigm. The 510(k) final guidances follow a series of premarket review guidance documents released over the past two weeks that also address modernizing approaches to risk analysis methods. See our client alerts on the De Novo RTA checklist, Humanitarian Device Exemption Program, and the new benefit-risk decision tree for PMAs and De Novos.

On 31 October 2019 FDA will host a webinar on the Special 510(k) final guidance.

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.

In association with
Related Topics
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