2023年3月29日eSTAR提出に対する指針がアップデートされました。 eSTARは医療機器提出準備の過程をのためのPDF様式です。 このテンプレートには次の要素が含まれております。 Automation (for example, form construction and autofill) Content and structure that is complementary to CDRH internal review templates Integration of multiple resources (for example, guidances and databases) Guided construction for each submission section Automatic verification 提出方法はCDRHを通してオンラインで提出する必要が..

Guidelines for eSTAR submissions updated on March 29, 2023. The eSTAR is a PDF form for the process of preparing a medical device submission. This template contains: - Automation (for example, form construction and autofill) - Content and structure that is complementary to CDRH internal review templates - Integration of multiple resources (for example, guidances and databases) - Guided construct..

2023년 3월 29일 eSTAR 제출에 대한 지침이 업데이트 되었습니다. eSTAR는 의료 기기 제출 준비 과정을 위한 PDF 양식입니다. 이 템플릿에는 다음이 포함됩니다: l Automation (for example, form construction and autofill) l Content and structure that is complementary to CDRH internal review templates l Integration of multiple resources (for example, guidances and databases) l Guided construction for each submission section l Automatic verification ​ 제출 방법은 CD..