The FDA has issued several revised guidance documents this month to support the updated 510k premarket notification pathway for devices which are modified versions of already approved devices. Readers will recall the 510k review is a determination that a new device is Substantially Equivalent (SE) to an existing approved device. The updated guidances are:
- The Special 510k Program – Guidance for Industry and Food and Drug Administration Staff,
- The Abbreviated 510k Program – Guidance for Industry and Food and Drug Administration Staff, and
- Refuse to Accept Policy – Guidance for Industry and Food and Drug Administration Staff.
The Special 510k guidance has been significantly changed. Instead of being limited to changes that did not alter the intended use or alter the devices fundamental scientific technology, the program will now look at whether the methods to evaluate the change are well established and whether the results can be reviewed in a summary or risk analysis format. This is a big change, and I believe it’s aligned with the agency’s intent to manage devices that use machine learning or AI. The other two guidances were updated to align the entire program. The agency will host a webinar on October 31st to discuss the updates and answer questions – this might be one you want to attend.
Reach out to me if you want to know more or discuss your medical product development challenges.
https://calendly.com/katrinarogers
Text Copyright © 2019 Katrina Rogers