Press Release

Regulation Analysis: FDA Publishes Links to De Novo Summaries

November 26, 2013

On Nov 21, 2013, the FDA published links to the De Novo Summaries. The significance of this is that these summaries may be used as a predicate for future 510(K) submissions.

The FDA published Guidance for De Novo Classification Process (Evaluation of Automatic Class III Designation) in 2011. The guidance is to facilitate a route to market for low or moderate risk devices that do not have a predicate and therefore have been classified as class III – device deemed to be not substantially equivalent (NSE) to legally marketed predicate devices.

Contact  Vesna Janic,  StarFish Medical Director of QA/RA, for information and advice on how this may impact your 501(k) submissions.

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