FDA releases two final guidance documents: Deciding When to Submit a 510(k)

The guidance applies to changes made to medical devices placed on the US market and includes sections on sterilisation and biocompatability

The US Food and Drug Administration (FDA) has released two final 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 and complements the broader guidance document.

Medical device technology is constantly evolving, and not all changes made to existing devices require FDA’s review. These guidances are intended to provide recommendations 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 require FDA review, including changes that could significantly affect the safety or effectiveness of a device and major changes or modifications to a  device’s intended use. 

These guidance documents supersede Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1), issued in 1997.

The final guidances build on the key concepts described in Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1), published 10 January, 1997, with targeted changes to provide additional clarity on when a new 510(k) is needed. Changes include clarification of key terms, explanation on how to use risk assessment to evaluate whether or not a change requires a new 510(k), harmonisation 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.

The FDA says this guidance does not specifically address combination products, such as drug/device or biologic/device combinations; however, the general principles and concepts described in it may be helpful to manufacturers in determining whether submission of a 510(k) is required for changes to device constituent parts of combination products.

The guidance does discuss changes to sterilisation methods and bicoompatability changes.

For example, it says “Change from “established category A” sterilization methods to “established category B” or “novel” sterilization methods generally require submission of a new 510(k). Changes from one “established category A” method to another “established category A” method, or from an “established category B” or “novel” method to an “established category A” method, should be evaluated under B3.2”.

The document can be downloaded at: www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm514771.pdf