Medical Device Update: FDA Issues Final Guidance on 510(k) Determinations, Use of “Split” Predicates Strongly Discouraged

by Morgan Lewis
Contact

On July 28, the Food and Drug Administration (FDA) issued a final guidance titled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].”[1] Device manufacturers should be aware of key changes to FDA’s policies that may affect their 510(k) submissions, including new limitations on the use of multiple predicates, the unacceptability of split predicates, an increase in the content and detail required for 510(k) summaries, and FDA’s intent to “verify the accuracy and completeness” of 510(k) summaries. In describing the critical decision points of the 510(k) review process, the final guidance emphasizes how safety and effectiveness are considered during the review. The inclusion of this discussion is likely in response to criticism of the 510(k) process in recent years.

The newly issued guidance finalizes the draft version, which issued on December 27, 2011 and supersedes the Center for Devices and Radiological Health Premarket Notification Program, 510(k) Memorandum 86-3 (June 30, 1986). The final guidance does not include sections on the Special and Abbreviated 510(k) programs, which were included in the draft version; these will be included in a separate guidance document.

Provided below is a summary of the final guidance.

Use of Multiple Predicates/“Split” Predicates

In the new guidance, FDA encourages manufacturers to identify a single predicate device to demonstrate substantial equivalence, but it does not prohibit using multiple predicates. However, FDA states that “split predicates,” which identify one predicate for the intended use and another predicate for the technological characteristics, are “inconsistent with the 510(k) regulatory standard.” Section 513(i) of the Federal Food, Drug, and Cosmetic Act defines “substantial equivalence” as a device with the same intended use as the predicate device and the same technological characteristics or different technological characteristics that do not raise different questions of safety and effectiveness than the predicate device. Although the guidance does not state explicitly that split predicates will not be accepted, the clear implication is that using split predicates will not lead to a finding of substantial equivalence. When multiple predicates are used, the guidance recommends that there be a “primary predicate,” with indications for use and technological characteristics that are most similar to the device that is the subject of the 510(k).

The guidance provides examples of when multiple predicates are appropriate, including, for example, when combining features from two or more predicate devices with the same intended use into a single new device, when seeking to market a device with more than one intended use, or when seeking more than one indication for use under the same intended use. The guidance also states that manufacturers may use a “reference device” to support scientific methodology or standard reference values (e.g., to characterize the coating on an orthopedic implant).

Intended Use

FDA clarifies the meaning of the terms “intended use” and “indications for use,” noting that “intended use” means the general purpose of the device or its function and that it includes the indications for use. “Indications for use” describes the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the target patient population. To be determined substantially equivalent, the device’s indications for use must fall within the intended use of the predicate device. The guidance describes that a change in indications for use will result in a new intended use when the change in indications for use raises different questions of safety and effectiveness (e.g., a change from a diagnostic indication to a screening indication or vice versa, a change in the patient population, or a change in the anatomical structure of use).

Technological Characteristics

In any 510(k) review, FDA evaluates whether there are technological differences between the new and predicate devices. If differences exist, FDA then determines whether those differences raise different questions of safety and effectiveness. The guidance states that key characteristics that FDA will consider include device design, materials, and energy sources. To assist manufacturers in assessing whether there are different questions of safety and effectiveness, the guidance includes several examples. These include changes in energy from mechanical to electrical and changes in the mode of application of a device.

Performance Data

The guidance states that, although descriptive information alone may be sufficient to demonstrate substantial equivalence in some cases, performance data are typically needed. This may be nonclinical bench performance testing and/or clinical testing. The guidance provides examples of when clinical data may be required. These include when there is a new or modified indication for use, when there are technological differences that raise different questions of safety and effectiveness, and when nonclinical test methods are not validated, are limited, or are inappropriate to demonstrate substantial equivalence.

510(k) Summary

Although 510(k) summaries are a required element of a 510(k) submission and their content is prescribed by FDA regulation, there is significant variability in the content of such summaries. For example, for 510(k)s filed by a manufacturer for improvements or changes to its cleared device, it is often difficult to determine from the summary how a particular device was modified. Further, a summary does not always reveal whether clinical testing was conducted to support substantial equivalence. To provide greater transparency and better ensure that the 510(k) summary reflects the information provided in a submission, the final guidance provides detailed information on the content of the 510(k) summary. For example, a sample summary is provided as an appendix and includes a listing of technological differences from the predicate and a summary of the nonclinical and clinical testing performed.

[1]. View the guidance here.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Morgan Lewis | Attorney Advertising

Written by:

Morgan Lewis
Contact
more
less

Morgan Lewis on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):
hide

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.

Security

JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.