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

Abstraction: FDA guidance on when device modifications require new 510(k) submission

Key points:

• FDA guidance document (docket FDA-2011-D-0453) superseding the 1997 K97-1 guidance on 510(k) premarket notification requirements for device changes
• Issued by the Center for Devices and Radiological Health; effective since February 2020
• Goal is to enhance predictability, consistency, and transparency of the "when to submit" decision using a least-burdensome approach
• Grounded in the Medical Device Amendments to the FD&C Act (1976) framework
• Provides detailed regulatory framework, policies, and practices underlying the submission decision rather than implementing new policy changes

Connections: Fda · Medical Device Regulation · Regulatory Compliance

Source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device