FDA Releases Performance Testing Guidance

May 10, 2019

The FDA issued final guidance on the information devicemakers need to include in test reports for non-clinical bench performance testing for their premarket submissions.

Device premarket submissions include premarket approval applications, humanitarian device exception applications, 510(k) submissions, investigational device exemption applications and de novo requests.

The guidance, which replaces draft guidance issued in May 2018, defines non-clinical bench performance testing as performance testing, performed by either a device manufacturer or a third-party testing facility, which encompasses all bench testing and will be dependent on the specifics of the actual device or device type.

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