Groups Suggest Changes to Software 510(k) Guidance
AdvaMed says it supports the principles and concepts in an FDA draft guidance on deciding when to submit a 510(k) for a software change to an existing medical device. The trade association provides recommendations on specific examples in the draft and more detailed comments. “Notwithstanding these comments,” it says, “we believe the draft guidance is clear, well-written, and easy to use, and we recommend the agency maintain the format for the final version of this document.”
Boston Scientific says it appreciates the agency’s efforts to modernize a 1997 guidance, and especially an updated reference to the Quality System Regulation. “A new 510(k) is not necessary for some types of changes and reliance on existing quality system requirements may reasonably assure the safety and effectiveness of the changed device,” it says. The comment letter identifies areas the company believes need to be further addressed to bring incremental clarity, address inconsistencies within the document and with the regulatory intent, and address practical implementation concerns.
The 510(k) Coalition says the draft “exemplifies a strong step forward in clarifying and defining the processes for when a modification would trigger a new 510(k) to be submitted on behalf of a sponsor.” Since many of the changes or modifications to devices are complex, the letter says, “it is important for FDA to clarify what controls would be in place to determine if a change that involves both a software and a hardware change occur would fall under the draft guidance or the previous draft guidance on deciding when to submit a 510(k) for a change to an existing device.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. We feel that the line between software and hardware changes needs to be as clear as possible when this guidance goes to final form.”
GE Healthcare asks for a single guidance for hardware and software changes. “The same regulatory requirements apply to all medical devices, irrespective of software or hardware,” it says. “As such, there is no legal framework for having different considerations for changes to software and hardware medical devices regarding when to submit a 510(k). Having a separate software guidance may suggest that 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.”
Finally, the Cybersecurity for Health Care Alliance says it supports the guidance provision that changes made to strengthen cybersecurity will likely not require a new 510(k). “Cybersecurity updates are critical to this discussion,” it says, “as they do not impact usability, safety, or function of the medical device; ensure patient safety in a timely fashion; and protect connected systems at health delivery organizations.”