FDA Report to Congress: 1997 Guidance Provides Solid Foundation for 510(k) Modification Decisions

by Holland & Knight LLP

  • Interested stakeholders have until June 4, 2014, to comment on the FDA's long-anticipated report to Congress that includes its Proposed Policy on the Premarket Notification Requirements for Modified Medical Devices. The FDA will make only targeted changes to its 1997 guidance in this area.
  • Medical device companies are among those parties who are well advised to submit comments, since Congress is closely watching the FDA on this issue, and given the influence the policy will have on regulatory pathway strategies.

On January 7, 2014, the U.S. Food and Drug Administration (FDA) delivered to Congress its long-anticipated report containing its Proposed Policy regarding the Premarket Notification Requirements for Modified Medical Devices (Report).1 The Report was mandated by section 604 of the Food and Drug Administration Safety and Innovation Act (FDASIA)2 and was made publicly available on February 26, 2014. Interested stakeholders have until June 4, 2014 to submit comments in response.

Signed into law on July 9, 2012, FDASIA revised many aspects of the FDA's regulatory oversight of medical devices. Section 604 of FDASIA found its way into the law as a result of intense industry advocacy to stop the FDA from implementing its 2011 draft guidance titled, 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device (July 27, 2011), which the FDA intended to replace its original 1997 guidance on the subject.3 Although the FDA believed it was only updating its 1997 guidance, the 2011 draft guidance represented a significant sea change that would have substantially delayed the introduction of the vast majority of medical devices into the U.S. market.

Section 604 required the FDA to (a) withdraw this draft guidance (which it did on July 17, 2012), (b) reinstate the 1997 guidance by the same title that industry had come to rely upon, and (c) report to Congress its plan to improve the 1997 guidance by providing specific definitional clarity.

Current Premarket Notification Requirements for Modified Devices

In general, under current FDA regulations, a person must provide premarket notification for a medical device if "the device is one that the person currently has in commercial distribution or is reintroducing into commercial distribution, but that is about to be significantly changed or modified in design, components, method of manufacture, or intended use."4 Regulations further state that "significant changes" requiring premarket notification include "(i) a change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process, [or] (ii) a major change or modification in the intended use of the device."5 This is the requirement that has been at the heart of the dispute that led to Section 604 and the FDA's recent Report to Congress.

FDA's Proposed New Policy for Modified Devices

In its Report, the FDA recognizes that the 1997 guidance remains "a solid foundation and should remain mostly unchanged."6 The FDA's proposed new policy for modified devices therefore preserves its existing policy as established in 1997, subject to certain limited updates, including: (1) explanation of key regulatory terms, (2) clarification of the process to determine a modified device's precise regulatory obligation, and (3) increased leverage of existing quality system requirements.

Explanation of Key Regulatory Terms

FDASIA mandated that the Report clarify the existing regulatory obligations by including the interpretation of certain key provisions, including: (1) "could significantly affect the safety or effectiveness of the device," (2) "a significant change or modification in design, material, chemical composition, energy source, or manufacturing process," and (3) "a significant change or modification in design, material, chemical composition, energy source, or manufacturing process."7 In the Report, the FDA has declined to promulgate specific definitions. Rather, the FDA will seek to explain these terms through an illustrative model that is in keeping with the flexible approach set forth in the 1997 guidance, subject to additional clarification.8

Clarification of Process to Determine a Modified Device's Regulatory Obligation

In the Report, the FDA acknowledges that certain aspects of the 1997 guidance are vague, unclear, and may allow for conflicting interpretations.9 To address these issues, the FDA proposes a number of targeted revisions to the 1997 guidance, including:

  • greater emphasis on the importance of design verification and validation activities, both as part of an overall quality system program and as a means to assess whether a modification could significantly affect the device's safety or effectiveness
  • additional considerations to aid in the assessment of the impact of changes to device materials, particularly when suppliers refuse to disclose material compositions, such as to maintain trade secrets
  • updated guidance regarding modifications involving new technologies, such as software and mobile devices, that better reflects the current state of medical device technology
  • increased clarification of the text of 1997 guidance, as well as better alignment between the text and associated flowcharts, which can be difficult to interpret on their own
  • addition of two new appendices, which will contain: (1) additional examples of device changes that likely would and would not require separate 510(k) clearance, and (2) guidance on how to appropriately document the process of determining a given modified device's regulatory obligation

Leverage of the Quality System Requirements

Quality system requirements ensure the safety and effectiveness of modified devices that do not require 510(k) clearance, thereby reducing the premarket regulatory burden on manufacturers and increasing the overall efficiency of the FDA's premarket oversight of medical devices.10 FDASIA mandated that the Report consider how existing quality system requirements can be better leveraged to reduce premarket burden, facilitate continued device improvement, and provide reasonable assurance of the safety and effectiveness of modified devices.11 In the Report, the FDA does not discuss specific options to achieve these objectives, but does state that the FDA will continue to seek input from interested parties, indicating that manufacturers and other industry stakeholders can look forward to further opportunities to engage the FDA on this subject.

In fact, on March 6, 2014, the agency published a Federal Register Notice soliciting comments on the Report.[12] Again, stakeholders have until June 4, 2014 to submit comments to the FDA. Medical device companies would be wise to take advantage of this opportunity to submit comments, knowing that Congress is watching the FDA closely on this issue, and given the influence the ultimate policy will have on thousands of regulatory pathway strategies.

1 See FDA, Report on FDA's Policy to be Proposed Regarding Premarket Notification Requirements for Modifications to Legally Marketed Devices (Feb. 26, 2014) [hereinafter FDA Modified Device Report].

2 See 21 U.S.C. §360(n)(2).

3 See FDA, Deciding When to Submit a 510(k) for a Change to an Existing Device (Jan. 10, 1997)

4 21 C.F.R. §807.81(a)(3).

5 Id. (emphasis added).

6 Id. at ii.

7 See 21 U.S.C. §360(n)(2).

8 See FDA Modified Device Report, supra note 1, at 16.

9 See id. at 16-18.

10 See id. at 18-19.

11 See 21 U.S.C. §360(n)(2).

12 See Notice of Public Availability of Report on FDA Policy to be Proposed Regarding Modifications to Legally Marketed Devices 79 Fed. Reg. 12695 (Mar. 6, 2014).

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.

© Holland & Knight LLP | Attorney Advertising

Written by:

Holland & Knight LLP

Holland & Knight LLP 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):

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.


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.