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

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FDASIA found its way into the law as a result of intense industry advocacy to stop the FDA from implementing its 2011 draft guidance titled, 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device (July 27, 2011), which the FDA intended to replace its original 1997 guidance on the subject.3 Although the FDA believed it was only updating its 1997 guidance, the 2011 draft guidance represented a significant sea change that would have substantially delayed the introduction of the vast majority of medical devices into the U.S. market.

Section 604 required the FDA to (a) withdraw this draft guidance (which it did on July 17, 2012), (b) reinstate the 1997 guidance by the same title that industry had come to rely upon, and (c) report to Congress its plan to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

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