Are you deciding on when to submit a 510(k) for a change to an existing device? As we have reported earlier, the US Food and Drug Administration (FDA) has finalized the guidelines on changes in medical devices that would need a 510(K) submission.

The guidance is expected to aid manufacturers of:

  • medical devices that are subject to premarket notification requirements with an intention to modify 510(k)-cleared device or group of devices
  • medical device(s) subject to 510(k) requirements viz. pre-amendments device or device which was granted marketing authorization through the De Novo Classification process

The guidance is not to address:

Though it has been mentioned that, the released guidance is expected to provide insights on device changes that require 510(k) submissions, the Agency, however, believes that 510(k) submission is not required for some types of device changes, and stresses on the least burdensome approach to follow to assure the safety and effectiveness of them, i.e., to rely on existing Quality System (QS) requirements. The QS regulation (21 CFR 820) requires finished medical devices manufacturers to review and approve design changes of devices and to document changes & approvals in the device master record.

To decide whether to use this guidance to submit a 510(k) based on changes to an existing device, the Agency listed out certain guiding principles to be followed, which are briefly listed here:

  • Changes made with an intent to affect the safety and effectiveness of a device
  • Initial risk-based assessment
  • Unintended consequences of changes
  • Use of risk management
  • The role of testing in evaluating how the device change can affect safety and effectiveness
  • simultaneous changes evaluation
  • Appropriate comparative device and cumulative effect of changes
  • Documentation requirement
  • 510(k) submissions for modified devices
  • Substantial equivalent determinations

While, the provided details cover few aspects of guidance, there is a broad detailing needed to completely decode the device changes that require 510(k) Submissions. On a conclusive note, FDA has added that the companies have to confirm the need for change through a verification and validation process which suggest partnering with adept Regulatory practitioner. As a strategic Regulatory partner to 10+ of the global top medical device companies, Freyr has efficiently handled 510(k) submissions and is continuously helping clients clear the devices in multiple cases. 



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