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Background on eSTARThe electronic submission template and resource (eSTAR) template can be used to submit US FDA Premarket Notifications (510(k)s), De Novos, and Traditional Premarket Applications (PMAs). eSTAR was compulsory for 510(k) submissions starting in October 2023. eSTAR will be required for De Novos starting in October 2025.eSTAR version 5.5eSTAR Version 5.5 was released (February 12)...

We last wrote about the U.S. FDA eSTAR when it became compulsory for 510(k)s. At the time, the eSTAR was voluntary for De Novos. Background on De NovosThe De Novo Classification Request “De Novo” is the regulatory mechanism used when manufacturers have a novel medical device that they expect is not high risk and so should be Class II (special controls and general controls) or Class I (general co..

미 FDA에서 510(k) 허가를 위한 서류 제출방식 가이던스를 발간하였다. ▶ 적용시점 FDA is identifying October 1, 2023 as the date on which the 510(k) electronic submission requirements will take effect. ▶ Scope This guidance describes the technical standards associated with preparation of the electronic submission template for 510(k)s that enable submission of the 510(k) electronic submission solely in electronic format. The el..