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# Webinar Explains 510(k) Change Guidance
- URL: https://www.fdaweb.com/webinar-explains-510-k-change-guidance/
- Published: 2017-11-29T12:00:00.000Z
- Updated: 2026-09-14T23:03:59.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140226

A 11/16 FDA [webinar](https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm581811.htm?ref=fdaweb.com) explained requirements in two recent final guidances on when to submit a 510(k) for a change to an existing device and when to submit a 510(k) for a software change to an existing device. During the program, CDRH acting associate director for regulations and guidance **Rebecca Nipper** outlined the 10 principles that underlie both guidances: 

- if a change is intended to significantly affect the safety or effectiveness of a medical device, such a change would likely require a new 510(k) submission;
- make a risk-based assessment to determine whether a change would significantly affect the device and confirm any decision that a new 510(k) is not required through routine verification and validation activities;
- after considering whether a change was made with the intent to significantly affect safety or effectiveness, also consider whether the change could have unintended consequences;
- risk management plays a central role in determining when a change could significantly affect safety or effectiveness;
- when there are multiple changes, they should be assessed both separately and together;
- conduct a risk-based assessment comparing the changed device to the device even previously found to be substantially equivalent in the most recently cleared 510(k);
- when the cumulative effect of individual changes triggers the regulatory threshold for submission, submit a new 510(k);
- when a change is made to a device, comply with the Quality System regulation requiring, among other things, that device changes be documented;
- when a 510(k) is submitted for a device with multiple changes, it should describe all changes that trigger the requirement for submission of a new 510(k) as well as other changes since the most recent 510(k);
- even though one correctly follows the guidance and submits a new 510(k) when necessary, a substantially equivalent determination is not assured.