The US FDA has recently issued updated recommendations to assist manufacturers in determining when the FDA needs to be notified of modifications to certain medical devices that are already on the market. When finalized, the draft guidance will replace the existing policies that have been in place since 1997. An attempt to update the 1997 guidance was made and rejected in 2011, as the industry reacted unfavorably to the new requirements which they felt were excessively rigorous and would result in unnecessary regulatory oversight for products where none had previously existed.
The updated draft guidance preserves the basic format and content of the original 1997 guidance, however, additional information has been included several sections to add clarity for the manufacturers. The objective of the guidance is thusly two-fold as it intends to increase consistent interpretations of the guidance and ensure efficient, compliant decision-making for the manufacturer while in parallel, allowing the regulator to only receive appropriate submissions for device modifications and avoid any undue and burdensome administrative work.
In regard to the additional information included in the document, of particular note are the updates to the existing flowcharts, which are intended to be used a logic-tree in guiding the manufacturer toward a clearer understanding of their regulatory obligations. These flowcharts are separated into different categories, with distinct charts for device modifications that relate to labelling, technology, engineering, performance and materials changes for both medical devices and IVDs, and are accompanied by detailed examples to offer manufacturers practical guidance on this decision making process.
In addition to these flowcharts, the new guidance document from the FDA has a focus on risk assessment and requires the manufacturer to consider these assessments as the basis for decision making in regard to device modifications impacting device safety and effectiveness.
While this is something that FDA historically has expected companies to consider in documenting changes internally, such specific recommendations for this documentation have never before been articulated in guidance. Specifically, the draft details the nature of the risk assessment to be undertaken:
“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.”
While the requirements of risk assessments being completed for a new device modification have been widely understood and implemented, the explicit focus on only “risks whose existence and characteristics are supported by objective scientific evidence” should afford manufacturers with the ability to create concise and meaningful risk-based decisions. However, given the presence of the risk-assessments individually in each of the flowcharts, the manufacturer is essentially guided to consider the risks at an individual, rather than aggregate level, therefore creating the potential to drive significantly more 510(k) submissions.
Additionally, the same release included a distinct guidance for manufacturers in regard to software medical devices. This is a reflection of the technological progression of medical devices since the original guidance’s release in 1997, and the FDA’s understanding that modifications to software device will create different considerations for the decision to submit a 510(k)
The software-specific document is intended to provide recommendations concurrently with the universal guidance and as such applies the same principles and reasoning behind decisions, but details flow charts and examples specific to software devices. Considerations regarding cybersecurity, the interaction between software and other components of a device as well as the need to consider the impact that even minor changes to programming code may have on the safety and performance of the device are discussed within this document.
Overall, the draft bears many similarities to the guidance originally issues in 1997, providing explanation and practical examples to further clarify those initial requirements and facilitate a structured and practical approach to the decision-making process for manufacturers in their submissions to the FDA. Given the industry’s hostile reaction to the draft document issued in 2011, the FDA has delivered a guidance with a high level of explanation that feels like a natural successor to the widely-accepted original document; however, the new issue is still a draft and the FDA is welcoming comments and suggestions for improvement until 7 November 2016. See the Federal Register Announcement (software-specific) or go directly to the regulations page (software-specific) to file your comments and suggestions.
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