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Rapundalo: FDA Issues Draft Guidance Regarding 510(k) Modifications

Tuesday, August 30, 2016   (0 Comments)
Posted by: Stephen Rapundalo
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On August 8th, FDA issued a draft guidance, Deciding When to Submit a 510(k) for a Change to an Existing Device, as an update to the original 1997 issuance. The new release provides considerable detail and discussion of documentation needed when a manufacturer considers making improvements to their existing products.


What kind of modification will require a new 510(k)? The draft guidance states that “the first question is always whether the change is being made with the intent to significantly improve the safety or effectiveness of the device, for example, in response to a known risk, adverse event, etc. If so, then the change likely ‘could significantly affect the safety or effectiveness’ and a new 510(k) likely must be submitted.” The reference to “intent” is new and rather subjective with no further clarity invoked.


Furthermore, the draft focuses on conducting risk assessments of the modified device to determine whether a new 510(k) is required, stating, “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. 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 the low probability of occurrence and low severity of harm.” This emphasis on risk assessment will cause many companies to rethink how they analyze changes. Under 21 C.F.R. § 807.81(a)(3), the issue is whether a change could significantly affect safety or effectiveness.


The draft guidance also addresses how to properly document a modification to a 510(k)-cleared device, and provides a sample “Regulatory Change Assessment,” more commonly known as a “Letter to File.” No more simple “Yes” or “No” answers…the section makes clear to manufacturers that more substantive explanation will be required.


Also of note, the draft explicitly addresses the ever-complex area of a change from a general to more specific use. However, the passage elicits more questions than it does clarity.

In sum, the draft guidance appears to be an improvement over the original 1997 guidance. It includes more detailed explanations and examples by FDA. But it deserves further scrutiny and elucidation in a number of key areas, as will help companies determine whether making incremental improvements will be justified.


Comments and suggestions regarding this draft document can be submitted to the FDA by November 7, 2016. Submit electronic comments to Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Identify all comments with docket number, FDA-2016-D-2021. For questions about this document regarding CDRH-regulated devices, contact the 510(k) Staff at 301-796-5640.


For questions regarding the use or interpretation of this guidance in the review of submissions to the Center for Biologics Evaluation and Research, contact the Office of Communication, Outreach and Development at 1-800-835-4709 or 240-402-8010 or by email at

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