Today the FDA released two draft guidance documents: “Deciding When to Submit a 510(k) for a Change to an Existing Device,” which applies to medical device changes broadly, and “Deciding When to Submit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These draft guidance documents build on the process described in “Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1),” published January 10, 1997 and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 Updates in the draft guidance documents include clarifying key terms, explaining how to use risk assessment to evaluate whether or not a change requires a new 510(k), harmonization of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We welcome your comments and suggestions regarding these draft guidance documents. On August 8, 2016, the comment period will be open for 90 days in the Federal Register under docket number FDA-2016-D-2021 for “Deciding When to Submit a 510(k) for a Change to an Existing Device” and FDA-2011-D-0453 for “Deciding When to Submit a 510(k) for a Software Change to an Existing Device.”
When finalized, these guidance documents will supersede “Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1)” issued in 1997.
On August 25, 2016, the FDA will hold a webinar for industry to discuss the draft guidance documents: “Deciding When to Submit a 510(k) for a Change to an Existing Device” and “Deciding When to Submit a 510(k) for a Software Change to an Existing Device.” We welcome your questions about these draft guidances, so please plan to participate. No registration is required.Webinar Details:
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.
To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join.php?i=PW8727223&p=6372193&t=c
Conference Number: PW8727223
Following the webinar, written transcript, audio recording and slides will be available at: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm411063.htm
If you have any questions, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2041, 301-796-7100 or at [email protected].
Food and Drug Administration
Center for Devices and Radiological Health