changes_to_FDA_510k.png

What happens you need to make a change to a device that’s been cleared via 510(k)?

We discuss the importance of decision making during this process and relevant guidance from the FDA.

The FDA just released updated guidelines on procedures regarding changes to 501(k) devices and software.

Such changes in design or manufacturing are very common in the industry, so it’s important to understand the regulations as it pertains to your device.

 

Listen Now:

Like this episode? Subscribe today on iTunes or SoundCloud.

Our guest today is Mike Drues, president of Vascular Sciences and international regulatory affairs consultant. He works with governmental agencies and medical device companies around the world.

Some of the topics discussed today include:

  • New FDA guidance on changes to 501(k) devices and software
  • Difference between FDA draft and final guidance
  • Keeping track of changes to medical devices in a “letter to file”
  • Limitations to FDA guidance flowcharts
  • Ways to notify the FDA of a change
  • Multiple changes made to an existing medical device
  • Going above and beyond to introduce quality controls for device changes

Additional Links:

Deciding When to Submit a 510(k) for a Change to an Existing Device

Deciding When to Submit a 510(k) for a Software Change to an Existing Device

Mike Drues on LinkedIn

Vascular Sciences 

greenlight.guru

Quotes by Mike:

All regulations in general should be thought of as a work in progress

Sometimes when companies screw this up, they find themselves dealing with the FDA and the FBI

Have a respect for the FDA, but do not fear them.


About The Global Medical Device Podcast:
medical_device_podcast

The Global Medical Device Podcast powered by greenlight.guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Like this episode? Subscribe today on iTunes or SoundCloud.