FDA Issues Draft Guidance on "Deciding When to Submit a 510(k) for a Change to an Existing Medical Device"

August 18, 2016

On August 8, 2016, the U.S. Food and Drug Administration (FDA) issued draft guidance on the important topic of deciding when to submit a new 510(k) premarket notification application (510(k)) for a change to an existing medical device.1 Manufacturers commonly make changes to their medical devices, including: labeling changes (e.g., adding a contraindication), changing one or more device materials (e.g., from stainless steel to titanium), and changing the device's specification(s) (e.g., to improve the device's performance).

Deciding when to submit a new 510(k) is important to the medical device industry because:

  • assembling, submitting, and gaining clearance for a 510(k) application can be time consuming, expensive, and logistically challenging;2
  • the FDA can stop the sale of a changed medical device lacking a new 510(k) premarket clearance; and
  • the U.S. Department of Justice (DOJ) (after referral from the FDA) can criminally prosecute device companies and executives for failure to obtain required additional clearances (e.g., a misbranding charge).3,4,5

The 2016 Guidance

The FDA's 2016 guidance,6 which runs 73 pages, is roughly divided into the following sections: guiding principles; decision aiding flow charts and accompanying clarifications; examples; and documenting a decision to not file a new 510(k). While a complete analysis of the 2016 guidance is beyond the scope of this alert, we've highlighted several important guidance aspects below.

Guiding Principles

The 2016 guidance lays out a set of higher-level guiding principles which manufacturers should consider when determining whether a new 510(k) submission is needed. The FDA first notes that modifications made with the intent to significantly affect safety or effectiveness of the device will likely require submission of a new 510(k) application.7 Also, even if a risk assessment concludes that safety and effectiveness will not be significantly affected, a situation can arise where the modification(s) significantly affect routine device evaluation, or where routine verification and validation activities produce unexpected issues. In these circumstances, the FDA notes that "any prior decision that a new 510(k) is not required should be reconsidered."8 The FDA also suggests employing risk management as an evaluating tool, and that changes should be assessed individually and in the aggregate.9 When submitting a new 510(k), the FDA recommends describing all changes that trigger the requirement for a new 510(k), as well as those additional changes that were made but do not trigger a new submission requirement.10 Finally, the 2016 guidance also suggests that if multiple changes are made, but only one change triggers the requirement for a new 510(k), then the changes "that do not require a new 510(k) may be immediately implemented, as long as those changes can be implemented independently of changes that do require a new 510(k)."11

Flow Charts and Accompanying Clarifications

Like the 1997 guidance, the 2016 guidance includes flow charts that aid in the 510(k) new filing decision-making process. Individual flow charts are included for: labeling changes; technology, engineering, and performance changes (separate charts for non-in vitro diagnostic devices, and in vitro diagnostic devices (IVDs)); and considerations for risk assessments of modified devices. Flow chart endpoints are binary, ending either in "New 510(k)" or "Documentation," and the flow charts are accompanied by text that expands on flow chart decision points.


Over thirty examples are provided in the 2016 guidance. Some examples appear to be based on recent court cases. For example, in the recent Vascular Solutions case,12,13 the government charged Vascular Solutions, Inc., and its CEO Howard Root, with conspiracy and several counts of introducing misbranded and adulterated devices into interstate commerce. The case outcome turned on whether the company's promotion of its Vari-Lase product line for the treatment of perforator veins (deeper veins) was outside of the general indication that was cleared by the FDA—which the government maintained covered only superficial veins. The jury ultimately acquitted the company and its CEO of all counts, finding that the general indication encompassed deeper veins.

Example 6 of the 2016 guidance, for instance, appears to be related to the Vascular Solutions case. Example 6 recites that a catheter guidewire was originally cleared for accessing specific tissues. The guidewire's manufacturer expanded the labeling to include tissues not found original labeling. The FDA asserts this expansion could significantly affect safety and effectiveness, and recommends submitting a new 510(k).

Documenting a Decision to Not File a New 510(k)

Appendix B of the 2016 guidance reminds readers that if the manufacturer "determines that the device modification(s) does not require a new 510(k), it should document the decision-making process and the basis for that conclusion."14 Appendix B includes a bulleted list of material that should be included in the documentation, including reference to the 2016 guidelines.


The comment period for the FDA's newly published draft 2016 guidance is currently open. Interested stakeholders should submit their comments for the agency's consideration, as these may result in favorable draft guidance changes.

For questions regarding new 510(k) applications, medical devices, submitting comments on the 2016 guidance, or any FDA regulatory issue, please contact David Hoffmeister or any member of the FDA or life sciences practices at Wilson Sonsini Goodrich & Rosati.

Jon Nygaard and Charles Andres contributed to the preparation of this alert.

1 "Deciding When to Submit a 510(k) for a Change to an Existing Device: Draft Guidance for Industry and Food and Drug Administration Staff" (the 2016 guidance), Food and Drug Administration, August 8, 2016; available at:
2 For 2011-2015, the average time to review a 510(k) application was 151 days, or almost half a year. This average review time does not take into consideration time spent by the 510(k) applicant answering FDA post-submission questions, which tolls FDA's clock. Review times vary by device category, and third party review can—for additional cost—shave time off of the review process.
3 See, e.g., "...Executives Convicted of Crimes Related to the Sale of Medical Devices," U.S. Department of Justice, July 20, 2016, available at:
4 As noted in the DOJ's press release: "The charge of violating the Food, Drug and Cosmetics Act provides for a sentence of no greater than one year in prison on each count, one year of supervised realse (sic) and fine of $100,000 or twice the gross gain or loss." Id.
5 The DOJ can also bring civil charges.
6 The FDA's current guidance on this topic was published in 1997. In 2011, the FDA attempted to update its 1997 guidance, but the agency was forced to withdraw the updated guidance by Congress in 2012. Congress also ordered the FDA to continue to operate under the 1997 guidance and further required the FDA to provide a report to Congress detailing when a new 510(k) is needed. See, e.g., A. Gaffney, "In Major Victory for Industry, FDA says Existing 510(k) Guidance to Remain 'Mostly Unchanged'," RAPS Regulatory Focus (2014), available at:
7 The 2016 guidance at 4.
8 Id. at 5.
9 Id.
10 Id. at 6.
11 Id.
12 For an account of the Vascular Solutions case that is readily accessible to the lay reader, see J. Carlson, "Vascular Solutions, CEO acquitted of federal charges in off-label case," StarTribune, February 26, 2016, available at:
13 United States v. Vascular Solutions, Inc., Cr. No. 14-926 (W.D. Tex. 2016).
14 The 2016 guidance, Appendix B, at 58.