FDA releases updated guidance for pre-certification programme

The pilot was launched last year with major technology companies such as Apple, Fitbit and Samsung taking part. It is designed so that organisations, rather than individual devices, are assessed on the performance of their high-quality software design, testing, and monitoring.

The approach is specifically based on how organisations demonstrate a culture of quality and organisational excellence (CQOE). More so, the FDA will be looking at how companies can respond to software issues, ensuring consumers have access to safe and effective products.

The updated model further states that the programme will be available to organisations of any size, following comments made by the public into whether the programme would only be available to large organisations.

The FDA also goes into detail about its ‘excellence appraisal’ system, which has been designed as a pre-certification step that allows companies to demonstrate excellence based on outcomes. The new appraisal system will identify company characteristics such as leadership, transparency, monitoring capabilities and more, to help the FDA assess the safety of software as medical devices (SaMD).

Whilst the current focus of the 1.0 version of the programme is in establishing processes for SaMD technologies, the FDA states that product types including software in a medical device (SiMD) and other software that could be considered accessories to medical devices will ultimately benefit from the programme.

You can read the full update here.


Reece Armstrong is a reporter for Digital Health Age. Coming from the North East of England, Reece has an MA in Media & Journalism and a BA in Popular & Contemporary Music from Newcastle University. Reach him on Twitter or email via: reece.armstrong@rapidnews.com

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