De Novo requests: FDA releases updated RTA checklist

On 9 September 2019 the U.S. Food and Drug Administration (FDA or the agency) issued its final guidance document entitled "Acceptance Review for De Novo Classification Requests."

The guidance replaces the 30 October 2017 draft guidance of the same name and describes the administrative steps FDA will take to either Refuse to Accept (RTA) or file a request for an evaluation of automatic class III designation (De Novo request).

Although the guidance is explicit that it does not change FDA's standard for when a product should follow the De Novo pathway, it does include some significant additions compared to the prior draft that manufacturers will need to heed. Particularly with respect to combination products regulated through the medical device pathways, sponsors must indicate whether a request for designation is needed and whether they have provided the certification or statement of notice related to patent that is required for therapeutic biologic and drug products.

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