Medical Devices

Webinar - Two Draft Guidance Documents Clarifying When to Submit a 510(k) for a Change to an Existing Device - August 25, 2016

Today the FDA released two draft guidance documents: "Deciding When to Submit a 510(k) for a Change to an Existing Device,” which applies to medical device changes broadly, and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device,” which focuses on software-specific changes.

Medical device technology is constantly evolving, and not all changes made to existing devices require FDA's review. These draft recommendations are intended to provide guiding principles to help manufacturers determine when an intended change to a legally marketed medical device subject to premarket notification (510(k)) requirements is significant enough to warrant FDA review, including major changes or modifications to the intended use that could significantly impact safety and effectiveness.

These draft guidance documents build on the process described in "Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1),” published January 10, 1997 and incorporates input from the FDA's 2013 public meeting on 510(k) device modifications and comments received in response to the FDA's Report to Congress on 510(k) device modifications. Updates in the draft guidance documents include clarifying key terms, explaining how to use risk assessment to evaluate whether or not a change requires a new 510(k), harmonization of flowcharts with the text of the guidance, examples of device changes that would or would not require a new 510(k), and recommendations for documenting decisions about whether or not to submit a new 510(k) for a device change.

We welcome your questions about these draft guidance documents, so please mark your calendars to participate.

Webinar Details:

Registration is not necessary

Date: August 25, 2016
Time: 1:00 -2:30 PM, Eastern Time.
To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar.

NOTE: You must dial-in to hear the presentation and ask questions:  
Dial: 888-606-7035, passcode: 6372193
International Callers Dial: 1-517-308-9367

To view the slide presentation during the webinar:
Conference Number: PW8727223

Following the webinar, written transcript, audio recording and slides will be available at:

NOTE: The FDA does not provide Continuing Education (CEU) or Certificates of Attendance for webinar attendance.

Target Audience: Industry

If you have any questions regarding this guidance document, please contact CDRH's Division of Industry and Consumer Education (DICE) at, 1-800-638-2041, or 301-796-7100.

Food and Drug Administration
Center for Devices and Radiological Health

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Page Last Updated: 09/01/2016
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