Comments on Device Software Change Guidance
The 510(k) Coalition says in a comment letter that an FDA draft guidance on “Deciding When to Submit a 510(k) for a Change to an Existing Device,” exemplifies a strong step forward in clarifying and defining the process for when a modification would trigger a new 510(k) to be submitted on behalf of a sponsor. The group asks the agency to clarify what controls should be in place to determine if a change that involves both software and a hardware change occur would fall under this guidance or under the draft guidance on “Deciding When to Submit a 510(k) for a Change to an Existing Device.” Knowing the bounds of how to determine which to follow is important in making these two guidances as useful as possible for industry and will lead to submissions being submitted correctly for FDA, it says. “We feel that the line between software and hardware changes needs to be as clear as possible when this guidance goes to final form,” the coalition says.
Medtronic says the result of FDA’s outreach to industry and willingness to listen and collaborate on the draft guidance has been a “clear, usable, and logical guidance document.” It suggests that an even closer alignment of the two guidances would be beneficial to industry. “In particular,” Medtronic writes, “the differences in risk management criteria between the two draft guidance documents pose some special challenges.” The company provides comments and proposed changes.
Regulatory Compliance Associates, a consulting firm, comments that the guidance document does not specifically address the risk of the software and how the document should be used to assess software changes based on the distinctions between the different Software Levels of Concern. The firm says it would be helpful for the document to include general recommendations related to the bundling of software changes over time and the minimum/maximum recommended time frames for which a manufacturer must assess such changes between the various version levels of the software.
Baxter suggests that segregating the draft software guidance from the draft existing device guidance is a necessary step to align the documents with the agency’s current thinking around software and medical devices, specifically the unique measures a manufacturer must consider throughout the device lifecycle. In the company’s specific comments, it asks the agency to reconsider the current thinking about probability for harm in correlation with software defects.
GE Healthcare calls for FDA to consider providing a single guidance with general principles for all medical devices, inclusive of software or hardware. “There is no legal framework for having different considerations for changes to software and hardware medical devices regarding when to submit a 510(k),” the company writes. “Having a separate software guidance may suggest that the quality systems, risk management, and 510(k) decision making processes should differ for hardware and software devices, which we do not believe to be the agency’s intent…. Rather than creating a redundant document and potentially confusing sponsors when each should be used, GE Healthcare recommends that FDA consolidate the software guidance into the general guidance, adding software specific considerations and examples as needed in the relevant sections and appendices.”
Cybersecurity for Health Care Alliance says that FDA’s incorporation of how to address cybersecurity enhancements in the draft guidance is extremely important to the healthcare industry.
AstraZeneca asks FDA for more information on the agency’s thinking on software-containing device constituents of combination products.
Finally, AdvaMed says it commends FDA’s work on the draft guidance and is supportive of the principles and concepts it conveys. It provided several recommendations on specific examples in the draft.