New Draft Guidance Released on 510(k) Submissions

For much of my career, I have relied on the trusty K97 Memo, “Deciding When to Submit a 510(k) for a Change to an Existing Device,” released in January 1997. This guidance has served the U.S. Food and Drug Administration (FDA) and overall medtech industry well for nearly 20 years, but the document is in serious need of an update. Thus, I was thrilled to learn the FDA issued a new draft guidance in August, albeit with the same title.

K-97 Memo (Existing Guidance) 
One of the most striking differences between the draft guidance and the K-97 Memo is its size—the new compilation of regulations is more voluminous, totaling 73 pages (its predecessor is a “mere” 39 pages). The additional content is helpful, though. 

The introductions of both guidances are similar. 

The draft guidance replaced the K-97 Memo section titled, “The 510(k) Process and Good Manufacturing Practices” with a “Background”segment. This new background section is comprised of two key elements: why the FDA is proposing the new guidance, and an updated portion on “The 510(k) Process and the Quality System Regulation.” The most remarkable aspect of the change in this section is the statement that the draft guidance “preserves the basic format and content of the original, with updates to add clarity. The added clarity is intended to increase consistent interpretations of the guidance by FDA staff and manufacturers.” In my opinion, the draft guidance does just what it is intended to do. 

The scope of the draft guidance is the same as the original K-97 Memo, but it has been updated to add clarity. The scope of the draft guidance addresses recalls, which reads in part as follows: “This guidance, when finalized, may be useful in determining whether a new 510(k) is warranted in cases where the correction does alter the device.”

The draft guidance also contains a “Guiding Principles” portion that replaces the “Assumptions/Axioms” section of the original K-97 Memo. The “Guiding Principles” section discusses the use of risk management and proves to be quite useful, as it helps develop the lens through which the proposed change(s) should be viewed. 

Additionally, the draft guidance contains a “How to Use This Guidance” section, which replaces the K-97 Memo section called “The Model.” This  section is also quite valuable because it clearly describes how the guidance document should be used. Although it may seem evident, this level of clarity is not often achieved in guidance documents. The K-97 Memo’s equivalent section “The Model” was not quite as clear.

The draft guidance sub-sections on “Labeling Changes,” “Technology Engineering, Performance Changes,” “Materials Changes,” and “Technology, Engineering, Performance, and Materials Changes for In-Vitro Diagnostic Devices,” which are part of Section 5 (“How to Use This Guidance”) remain substantially equivalent to the original K-97 Memo, though they have been updated to add clarity.

The biggest change proposed in the draft guidance document is sub-section E of Section 5, titled, “Considerations for Risk Assessments of Modified Devices.” The original K-97 Memo does not have a corresponding sub-section. This segment, provides guidance on the principal factors that should be considered when conducting a risk assessment to determine whether a device modification leads to a significant risk profile change. This section states that “manufacturers should use the risk assessment considerations discussed in conjunction with the logic schemes and decision-making flowcharts outlined…” The section references ISO 14971 and is in alignment with ISO 14971. Seems like good news, right? This section of the draft guidance notes that the “assessment of risk in deciding whether to submit a new 510(k) should identify all possible risks, and then focus on risks whose existence and characteristics are supported by objective scientific evidence.”

The section further states, “It is not necessary to focus on hypothetical risks that are not supported by scientific evidence or those that are determined to be negligible due to both low probability of occurrence and low severity of harm to determine whether the device modification could significantly affect safety or effectiveness and require a new 510(k).”

Here is my warning, based on my experience, about the aforementioned quote: Be careful. I find that at least some medical device manufacturers have underestimated risk due to under-evaluating the severity of harm and/or overestimating the effectiveness of risk controls. 

The risk assessment section of the draft guidance describes the relationship between hazards and harm, likelihood or probability of harm, and severity of harm in ways that align with ISO 14971:2007. Additionally, the section addresses device effectiveness, noting that the decision on whether to submit a new 510(k) due to a change depends not only on the change’s effect on safety, but also on effectiveness. “Manufacturers should also consider the possible effects a device modification may have on device effectiveness. As with safety risks, the manufacturer should consider the probability and severity (i.e., magnitude) of impacts to device effectiveness,” the guidance states. This avowal makes sense to me from a regulatory/quality perspective, but as the old saying goes, this is easier said than done. I recommend that when you are evaluating this draft guidance document, you thoroughly consider how you would integrate the device effectiveness into your risk management program. If you have integrated device effectiveness into your risk management program, I would love to hear about how you achieved  it. 

In summary, the changes proposed in the draft guidance document “Deciding When to Submit a 510(k) for a Change to an Existing Device” adds clarity and provides additional direction on risk management for device safety and effectiveness. If you have not yet reviewed this draft guidance document, I recommend that you do so.  The FDA is taking industry comments, and if you have concerns with the draft guidance document, I strongly encourage you to voice them with the agency.  

[Editor’s Note: Check out the latest Mike on Medtech at MPO’s website for more on this FDA guidance document.]

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James A. “Jim” Dunning’s consulting career began in 2001. He has provided quality and regulatory consulting services for various companies ranging from Fortune 500 medical device firms to startups. Dunning’s passion, however, lies with startups and small companies, especially those in regulatory distress. He has amassed significant experience in preparing 510(k) applications, developing complete Quality Management Systems, providing Quality System Training, and advising on quality, business, and leadership issues. Dunning is a senior member of the American Society for Quality (ASQ) and a member of the Regulatory Affairs Professional Society (RAPS). He can be reached at [email protected].