510k Modernization in progress

17 May 2019 |


In our live webinar of January 2019 “Making American Guidance Understandable Again”, we highlighted a range of FDA initiatives towards a modernization of the US Medical Device Regulations. During that webinar, we presented a new 510(k) framework, the “Safety and Performance Based pathway”.

This alternative 510(k) pathway has come to a reality in February, as FDA published their “Final Guidance on Safety and Performance Based Pathway”. The new program forms an extension of the Abbreviated 510(k) concept which allows manufacturers of well understood technologies to rely on objective criteria (from international standards) to demonstrate safety and performance.

For manufacturers, this presents significant advantages – a clear step away from the old form of predication which mostly relies on side-by-side testing to a US-cleared predicate. Reliance on product testing to international standards allows simplifications of test programs and harmonization with the requirements of other regions (e.g. Europe, Australia).

The FDA has held to their promise and have now delivered new sets of product specific guidance which detail how the Agency interprets international standards for certain technologies. Most recent guidance documents include:

The FDA is set to publish more standard guidance with corresponding FDA-identified performance criteria. Industry is invited to suggest device types for which FDA should consider identifying performance criteria. Input can be provided using the docket number FDA-2018-D-1387 at www.regulations.gov.

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