USA – MDUFA V: US FDA sets performance goals for De Novo medical device reviews

The US Food and Drug Administration (FDA) has issued a commitment letter describing draft amendments to its medical device review procedures. The agency is currently finalizing the process improvements detailed in FDA Medical Device User Fee Amendment V (MDUFA V). Once adopted, MDUFA V will set performance goals and procedures for medical device submissions for the fiscal years 2023 through 2027…